{
"NDC": [
{
"NDCCode": "59088-413-31",
"PackageDescription": "500 mL in 1 BOTTLE (59088-413-31) ",
"NDC11Code": "59088-0413-31",
"ProductNDC": "59088-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing With Lavender Oil",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200605",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M014",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200605",
"SamplePackage": "N",
"IndicationAndUsage": "■ Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "59088-413-06",
"PackageDescription": "1 BOTTLE in 1 KIT (59088-413-06) / 710 mL in 1 BOTTLE (59088-413-39) ",
"NDC11Code": "59088-0413-06",
"ProductNDC": "59088-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing With Lavender Oil",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200605",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M014",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200605",
"SamplePackage": "N",
"IndicationAndUsage": "■ Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "59088-413-36",
"PackageDescription": "1 KIT in 1 KIT (59088-413-36) / 1 BOTTLE in 1 KIT (59088-413-14) / 118 mL in 1 BOTTLE (59088-413-08) ",
"NDC11Code": "59088-0413-36",
"ProductNDC": "59088-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing With Lavender Oil",
"NonProprietaryName": "Alcohol",
"DosageFormName": "GEL",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200605",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M014",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200605",
"SamplePackage": "N",
"IndicationAndUsage": "■ Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "31722-413-31",
"PackageDescription": "5 CAPSULE in 1 BOTTLE (31722-413-31) ",
"NDC11Code": "31722-0413-31",
"ProductNDC": "31722-413",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Temozolomide",
"NonProprietaryName": "Temozolomide",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20240823",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA210030",
"LabelerName": "Camber Pharmaceuticals, Inc.",
"SubstanceName": "TEMOZOLOMIDE",
"StrengthNumber": "100",
"StrengthUnit": "mg/1",
"Pharm_Classes": "Alkylating Activity [MoA], Alkylating Drug [EPC]",
"Status": "Active",
"LastUpdate": "2024-10-22",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240823",
"SamplePackage": "N",
"IndicationAndUsage": "Temozolomide capsule is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1) Anaplastic astrocytoma. ( 1.2) o Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2) o Treatment of adults with refractory anaplastic astrocytoma. ( 1.2).",
"Description": "Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as-tetrazine-8-carboxamide. The structural formula of temozolomide is:. The material is a white to light pink or light tan powder with a molecular formula of C 6H 6N 6O 2and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide capsules can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients are anhydrous lactose, colloidal silica, sodium starch glycolate, stearic acid, tartaric acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Temazolomide Capsules USP, 5 mg:The opaque green cap contains FD&C Blue #2, gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 20 mg:The opaque yellow cap contains gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsule USP, 100 mg:The opaque pink cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules, USP, 140 mg:The opaque blue cap contains FD&C Blue #2, gelatin, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 180 mg:The opaque orange cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 250 mg:The opaque white cap contains gelatin, sodium lauryl sulfate, and titanium dioxide."
},
{
"NDCCode": "43419-413-31",
"PackageDescription": "2 CONTAINER in 1 CARTON (43419-413-31) > 15 g in 1 CONTAINER",
"NDC11Code": "43419-0413-31",
"ProductNDC": "43419-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Iope Air Cushion Intense Cover 23",
"NonProprietaryName": "Zinc Oxide, Octinoxate, And Titanium Dioxide",
"DosageFormName": "LOTION",
"RouteName": "TOPICAL",
"StartMarketingDate": "20180102",
"EndMarketingDate": "20201231",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part352",
"LabelerName": "AMOREPACIFIC CORPORATION",
"SubstanceName": "ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE",
"StrengthNumber": "1.47; 1.05; .6225",
"StrengthUnit": "g/15g; g/15g; g/15g",
"Status": "Deprecated",
"LastUpdate": "2021-01-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20180102",
"EndMarketingDatePackage": "20201231",
"SamplePackage": "N"
},
{
"NDCCode": "66129-413-31",
"PackageDescription": "50 g in 1 TUBE (66129-413-31)",
"NDC11Code": "66129-0413-31",
"ProductNDC": "66129-413",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Idole Natural Organic Skin Lightening",
"NonProprietaryName": "Hydroquinone",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110101",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part358A",
"LabelerName": "International Beauty Exchange",
"SubstanceName": "HYDROQUINONE; OCTINOXATE",
"StrengthNumber": "1; .25",
"StrengthUnit": "g/50g; g/50g",
"Status": "Deprecated",
"LastUpdate": "2019-09-21",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20171231",
"IndicationAndUsage": "For the gradual fading of dark (brownish) areas in the skin such as freckles, age and liver spots."
},
{
"NDCCode": "59088-201-31",
"PackageDescription": "480 mL in 1 BOTTLE (59088-201-31) ",
"NDC11Code": "59088-0201-31",
"ProductNDC": "59088-201",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Liquical Plus",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20240612",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHOLECALCIFEROL; ZINC CITRATE; MAGNESIUM CITRATE; CALCIUM CITRATE",
"StrengthNumber": "1200; 2.1; 72; 252",
"StrengthUnit": "[iU]/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240612",
"SamplePackage": "N",
"IndicationAndUsage": "LiquiCal Plus is indicated for dietary management of patients with unique nutritional needs requiring increased Vitamin D3 and essential minerals, including Calcium, Magnesium, and Zinc in a convenient liquid form for easy administration.",
"Description": "LiquiCal Plus Rx Only Full Prescribing Information. Active Ingredients: Each 5 mL Contains: Vitamin D3 (as Cholecalciferol) ................................................................. 10 mcg (400 IU) Calcium (as Calcium Citrate) ..................................................................................... 84 mg Magnesium (as Magnesium Citrate) ......................................................................... 24 mg Zinc (as Zinc Citrate) ................................................................................................ 0.7 mg. Each 15 mL Contains: Vitamin D3 (as Cholecalciferol) ............................................................... 30 mcg (1200 IU) Calcium (as Calcium Citrate) ................................................................................... 252 mg Magnesium (as Magnesium Citrate) ......................................................................... 72 mg Zinc (as Zinc Citrate) ................................................................................................ 2.1 mg. Other Ingredients: Agave Tequilana (Tequila Agave) Stem Extract, Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum."
},
{
"NDCCode": "59088-299-31",
"PackageDescription": "500 mL in 1 BOTTLE, DISPENSING (59088-299-31) ",
"NDC11Code": "59088-0299-31",
"ProductNDC": "59088-299",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Genrx Anti-bacterial Gel",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200318",
"MarketingCategoryName": "OTC MONOGRAPH DRUG",
"ApplicationNumber": "M014",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Active",
"LastUpdate": "2024-10-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200318",
"SamplePackage": "N",
"IndicationAndUsage": "Hand sanitizer to help reduce bacteria on the skin."
},
{
"NDCCode": "59088-332-31",
"PackageDescription": "500 mL in 1 BOTTLE, PUMP (59088-332-31) ",
"NDC11Code": "59088-0332-31",
"ProductNDC": "59088-332",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200424",
"EndMarketingDate": "20220531",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2022-06-01",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"StartMarketingDatePackage": "20200424",
"EndMarketingDatePackage": "20220531",
"SamplePackage": "N"
},
{
"NDCCode": "59088-370-31",
"PackageDescription": "473 mL in 1 BOTTLE (59088-370-31) ",
"NDC11Code": "59088-0370-31",
"ProductNDC": "59088-370",
"ProductTypeName": "HUMAN OTC DRUG",
"ProprietaryName": "Hand Sanitizing",
"NonProprietaryName": "Alcohol",
"DosageFormName": "LIQUID",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200515",
"MarketingCategoryName": "OTC MONOGRAPH NOT FINAL",
"ApplicationNumber": "part333A",
"LabelerName": "PureTek Corporation",
"SubstanceName": "ALCOHOL",
"StrengthNumber": "62",
"StrengthUnit": "mL/100mL",
"Status": "Deprecated",
"LastUpdate": "2020-07-02",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20211231",
"StartMarketingDatePackage": "20200515",
"SamplePackage": "N"
},
{
"NDCCode": "59088-659-31",
"PackageDescription": "480 mL in 1 BOTTLE (59088-659-31) ",
"NDC11Code": "59088-0659-31",
"ProductNDC": "59088-659",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Livita Adults",
"NonProprietaryName": "Folate, Multivitamin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20231215",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHOLINE BITARTRATE; CHOLECALCIFEROL; VITAMIN A ACETATE; ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; ZINC PICOLINATE; MAGNESIUM CITRATE; CALCIUM PANTOTHENATE; CALCIUM CITRATE; INULIN",
"StrengthNumber": "200; 10; 900; 200; 30; 1.2; 1.3; 8; 1.7; 1000; 2.4; 30; 2; 100; 5; 200; 500",
"StrengthUnit": "mg/15mL; ug/15mL; ug/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; ug/15mL; ug/15mL; ug/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231215",
"SamplePackage": "N",
"IndicationAndUsage": "Livita liquid is indicated to provide significant amounts of essential vitamins and minerals, including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, folate, calcium, magnesium, and zinc, to supplement the diet. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs of adults and children are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps in adults, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.",
"Description": "Active Ingredients: Amount Per Serving:. Vitamin A (as Retinyl Acetate).................................... 900 mcg RAE Vitamin C (as Ascorbic Acid)............................................... 200 mg Vitamin D3 (as Cholecalciferol)............................................ 10 mcg Vitamin E (as D-Alpha Tocopheryl Acetate)............................ 30 mg Thiamin (as Thiamine Mononitrate)...................................... 1.2 mg Riboflavin ............................................................................. 1.3 mg Niacin (as Niacinamide)........................................................... 8 mg Vitamin B6 (as Pyridoxine Hydrochloride)............................ 1.7 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)...1700 mcg DFE (1000 mcg of L-5-Methylfolate) Vitamin B12 (as Methylcobalamin and Hydroxocobalamin)...2.4 mcg Biotin (as D-Biotin)............................................................... 30 mcg Pantothenic Acid (as D-Calcium Pantothenate)........................ 5 mg Choline (as Choline Bitartrate)............................................. 200 mg Calcium (as Calcium Citrate)................................................ 200 mg Magnesium (as Magnesium Citrate).................................... 100 mg Zinc (as Zinc Picolinate)........................................................... 2 mg Inulin (as Helianthus Tuberosus Root Extract)..................... 500 mg. Other Ingredients: Aqua (Water), Organic Agave Syrup, Carrageenan, Citrus Extract, Flavor, Glycerin, Hydroxocobalamin Acetate, Potassium Sorbate, Organic Stevia Rebaudiana Leaf Extract."
},
{
"NDCCode": "59088-723-00",
"PackageDescription": "1 KIT in 1 KIT (59088-723-00) * 100 CAPSULE in 1 BOTTLE (62332-141-31) * 59 mL in 1 BOTTLE, SPRAY (GS1:7-31477-27221-7) ",
"NDC11Code": "59088-0723-00",
"ProductNDC": "59088-723",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Celexib 100-ezs",
"NonProprietaryName": "Celecoxib",
"DosageFormName": "KIT",
"StartMarketingDate": "20181022",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA204519",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-04-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20191231",
"StartMarketingDatePackage": "20181022",
"SamplePackage": "N"
},
{
"NDCCode": "59088-786-31",
"PackageDescription": "480 mL in 1 BOTTLE (59088-786-31) ",
"NDC11Code": "59088-0786-31",
"ProductNDC": "59088-786",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Liquical With Magnesium",
"NonProprietaryName": "Multivitamin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20231227",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CALCIUM CITRATE; CHOLECALCIFEROL; MAGNESIUM CITRATE; ZINC CITRATE",
"StrengthNumber": "168; 66; 48; 1.4",
"StrengthUnit": "mg/mL; [iU]/mL; mg/mL; mg/mL",
"Pharm_Classes": "Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2024-04-03",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20231227",
"SamplePackage": "N",
"IndicationAndUsage": "LiquiCal with Magnesium is indicated to provide support in children's healthy bone growth and development.",
"Description": "Vitamin D3 (Cholecalciferol): Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner. Calcium (Calcium Citrate): Calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet. Magnesium (Magnesium Citrate): Magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. Zinc Citrate: Zinc is an essential trace element that has a critical role in maintaining structural and catalytic functions of >200 enzymes involved in major metabolic pathways, including nucleic acid metabolism, protein synthesis, and cell division. OTHER INGREDIENTS: Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum, Xylitol."
},
{
"NDCCode": "59088-083-00",
"PackageDescription": "1 KIT in 1 PACKAGE (59088-083-00) * 9 BLISTER PACK in 1 CARTON (55111-292-09) / 9 TABLET in 1 BLISTER PACK * 85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) ",
"NDC11Code": "59088-0083-00",
"ProductNDC": "59088-083",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Migranow",
"NonProprietaryName": "Sumatriptan Succinate, Camphor, Menthol",
"DosageFormName": "KIT",
"StartMarketingDate": "20160418",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Active",
"LastUpdate": "2024-12-17",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20160418",
"SamplePackage": "N",
"IndicationAndUsage": "Sumatriptan tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of sumatriptan tablets have not been established for cluster headache, which is present in an older, predominantly male population.",
"Description": "Sumatriptan tablets USP contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine 1 receptor subtype agonist. Sumatriptan succinate USP is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C 14H 21N 3O 2SC 4H 6O 4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin."
},
{
"NDCCode": "59088-113-66",
"PackageDescription": "90 CAPSULE in 1 BOTTLE, PLASTIC (59088-113-66)",
"NDC11Code": "59088-0113-66",
"ProductNDC": "59088-113",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Purefe Ob Plus",
"NonProprietaryName": "Ferrous Fumarate And Polysaccharide Iron Complex",
"DosageFormName": "CAPSULE",
"RouteName": "ORAL",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "FERROUS FUMARATE; IRON DEXTRAN; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; MAGNESIUM SULFATE, UNSPECIFIED; ZINC SULFATE; CUPRIC SULFATE; MANGANESE SULFATE",
"StrengthNumber": "53; 53; 6; 30; 5; 1; 15; 10; 200; 10; 6.9; 18.2; .8; 1.3",
"StrengthUnit": "mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1",
"Pharm_Classes": "Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59088-115-60",
"PackageDescription": "6 BLISTER PACK in 1 CARTON (59088-115-60) > 1 KIT in 1 BLISTER PACK",
"NDC11Code": "59088-0115-60",
"ProductNDC": "59088-115",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Pnv Ob Dha",
"NonProprietaryName": "Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium, Docosahexaenoic Acid (dha)",
"DosageFormName": "KIT",
"StartMarketingDate": "20110601",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59088-210-16",
"PackageDescription": "227 g in 1 JAR (59088-210-16) ",
"NDC11Code": "59088-0210-16",
"ProductNDC": "59088-210",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Urea 39.5% With 2% Salicylic Acid",
"NonProprietaryName": "Urea, Salicylic Acid",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230324",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "UREA; SALICYLIC ACID",
"StrengthNumber": "39.5; 2",
"StrengthUnit": "g/100g; g/100g",
"Status": "Active",
"LastUpdate": "2023-03-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20230324",
"SamplePackage": "N",
"IndicationAndUsage": "For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, soothes rough and dry skin, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.",
"Description": "Urea 39.5% Cream with 2% Salicylic Acid is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin space. Each gram contains 395 mg of urea, 20 mg of Salicylic Acid in vehicle consisting of: Aqua (Purified Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylparaben, Simethicone, Sodium Hydroxide, Squalane, Stearic Acid. Urea is a diamide of carbonic acid with the following chemical structure."
},
{
"NDCCode": "59088-378-00",
"PackageDescription": "1 KIT in 1 PACKAGE (59088-378-00) * 5 g in 1 TUBE (0168-0357-05) * 1 in 1 BAG (GS1:19555240400625)",
"NDC11Code": "59088-0378-00",
"ProductNDC": "59088-378",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Venipuncture Cpi",
"NonProprietaryName": "Lidocaine And Prilocaine",
"DosageFormName": "KIT",
"StartMarketingDate": "20160509",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA076453",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2019-05-31",
"ProductNdcExcludeFlag": "E",
"ListingRecordCertifiedThrough": "20181231"
},
{
"NDCCode": "59088-660-16",
"PackageDescription": "237 mL in 1 BOTTLE (59088-660-16) ",
"NDC11Code": "59088-0660-16",
"ProductNDC": "59088-660",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Livita Children",
"NonProprietaryName": "Folate, Multivitamin",
"DosageFormName": "LIQUID",
"RouteName": "ORAL",
"StartMarketingDate": "20231218",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "CHOLINE BITARTRATE; CHOLECALCIFEROL; VITAMIN A ACETATE; ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; ZINC PICOLINATE; MAGNESIUM CITRATE; CALCIUM PANTOTHENATE; CALCIUM CITRATE; INULIN",
"StrengthNumber": "66.67; 3.33; 300; 66.67; 10; .4; .43; 2.67; .57; 333; .8; 10; .67; 33.33; 1.67; 66.67; 166.67",
"StrengthUnit": "mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL",
"Pharm_Classes": "Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]",
"Status": "Deprecated",
"LastUpdate": "2026-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20231218",
"SamplePackage": "N",
"IndicationAndUsage": "Livita liquid is indicated to provide significant amounts of essential vitamins and minerals, including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, folate, calcium, magnesium, and zinc, to supplement the diet. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs of adults and children are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps in adults, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.",
"Description": "Serving Size: 15 mL Servings per container: 47. Vitamin A (as Retinyl Acetate)........................ 300 mcg RAE Vitamin C (as Ascorbic Acid)............................... 66.67 mg Vitamin D3 (as Cholecalciferol)............................ 3.33 mcg Vitamin E (as D-Alpha Tocopheryl Acetate)............. 10 mg Thiamin (as Thiamine Mononitrate)......................... 0.4 mg Riboflavin .............................................................. 0.43 mg Niacin (as Niacinamide)......................................... 2.67 mg Vitamin B6 (as Pyridoxine Hydrochloride)............. 0.57 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)...566 mcg DFE (333 mcg of L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)......................... 0.8 mcg Biotin (as D-Biotin)................................................. 10 mcg Pantothenic Acid (as D-Calcium Pantothenate)..... 1.67 mg Choline (as Choline Bitartrate)............................. 66.67 mg Calcium (as Calcium Citrate)............................... 66.67 mg Magnesium (as Magnesium Citrate)...................... 33.3 mg Zinc (as Zinc Picolinate)........................................ 0.67 mg Inulin (as Helianthus Tuberosus Root Extract)... 166.67 mg. Other Ingredients: Aqua (Water), Organic Agave Syrup, Carrageenan, Citrus Extract, Flavor, Glycerin, Hydroxocobalamin Acetate, Potassium Sorbate, Organic Stevia Rebaudiana Leaf Extract."
},
{
"NDCCode": "59088-771-07",
"PackageDescription": "7 g in 1 TUBE (59088-771-07) ",
"NDC11Code": "59088-0771-07",
"ProductNDC": "59088-771",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "CREAM",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "30; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula. NGREDIENTS: PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 1% CreamEach gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 10 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 3% HYDROCORTISONE ACETATE 1%."
},
{
"NDCCode": "59088-771-20",
"PackageDescription": "20 TUBE in 1 KIT (59088-771-20) / 7 g in 1 TUBE (59088-771-01) ",
"NDC11Code": "59088-0771-20",
"ProductNDC": "59088-771",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "CREAM",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "30; 10",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-05-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"EndMarketingDatePackage": "20250530",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula. NGREDIENTS: PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 1% CreamEach gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 10 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 3% HYDROCORTISONE ACETATE 1%."
},
{
"NDCCode": "59088-798-00",
"PackageDescription": "1 KIT in 1 KIT (59088-798-00) * 1 BOTTLE, DROPPER in 1 CARTON (51672-1358-2) / 150 mL in 1 BOTTLE, DROPPER * 237 mL in 1 BOTTLE, PUMP (59088-310-16) ",
"NDC11Code": "59088-0798-00",
"ProductNDC": "59088-798",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lextol",
"NonProprietaryName": "Diclofenac Sodium, Capsaicin",
"DosageFormName": "KIT",
"StartMarketingDate": "20230825",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"Status": "Deprecated",
"LastUpdate": "2023-08-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20241231",
"StartMarketingDatePackage": "20230825",
"SamplePackage": "N"
},
{
"NDCCode": "59088-816-01",
"PackageDescription": "7 g in 1 TUBE (59088-816-01) ",
"NDC11Code": "59088-0816-01",
"ProductNDC": "59088-816",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "CREAM",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "20; 20",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. INGREDIENTS: PharmaPure Rx Lidocaine HCl 2% - Hydrocortisone Acetate 2% Cream. Each gram contains Lidocaine HCl 20 mg, Hydrocortisone Acetate 20 mg. ACTIVE INGREDIENTS. LIDOCAINE HCl 2% HYDROCORTISONE ACETATE 2%."
},
{
"NDCCode": "59088-817-01",
"PackageDescription": "1 TUBE in 1 KIT (59088-817-01) / 100 g in 1 TUBE (59088-817-07) ",
"NDC11Code": "59088-0817-01",
"ProductNDC": "59088-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"ProprietaryNameSuffix": "With Aloe",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "GEL",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "28; 5.5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"EndMarketingDatePackage": "20261231",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55%."
},
{
"NDCCode": "59088-817-07",
"PackageDescription": "100 g in 1 TUBE (59088-817-07) ",
"NDC11Code": "59088-0817-07",
"ProductNDC": "59088-817",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl - Hydrocortisone Acetate",
"ProprietaryNameSuffix": "With Aloe",
"NonProprietaryName": "Lidocaine Hcl And Hydrocortisone Acetate",
"DosageFormName": "GEL",
"RouteName": "RECTAL",
"StartMarketingDate": "20110701",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE",
"StrengthNumber": "28; 5.5",
"StrengthUnit": "mg/g; mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20110701",
"SamplePackage": "N",
"IndicationAndUsage": "Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.",
"Description": "Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55%."
},
{
"NDCCode": "59088-900-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-900-54) / 14 g in 1 POUCH (59088-900-84) ",
"NDC11Code": "59088-0900-54",
"ProductNDC": "59088-900",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan Vii",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240808",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocan VII is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocan VII is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59088-907-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-907-54) / 14 g in 1 POUCH (59088-907-84) ",
"NDC11Code": "59088-0907-54",
"ProductNDC": "59088-907",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan Iii",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "LIDOCAN III is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "LIDOCAN III is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59088-909-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-909-54) / 14 g in 1 POUCH (59088-909-84) ",
"NDC11Code": "59088-0909-54",
"ProductNDC": "59088-909",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan V",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20200514",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20200514",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocan V is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocan V is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59088-911-54",
"PackageDescription": "30 POUCH in 1 PACKAGE (59088-911-54) / 14 g in 1 POUCH (59088-911-84) ",
"NDC11Code": "59088-0911-54",
"ProductNDC": "59088-911",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocan Vi",
"NonProprietaryName": "Lidocaine 5%",
"DosageFormName": "PATCH",
"RouteName": "TOPICAL",
"StartMarketingDate": "20230615",
"MarketingCategoryName": "ANDA",
"ApplicationNumber": "ANDA209190",
"LabelerName": "PURETEK CORPORATION",
"SubstanceName": "LIDOCAINE",
"StrengthNumber": "50",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Active",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20261231",
"StartMarketingDatePackage": "20240621",
"SamplePackage": "N",
"IndicationAndUsage": "Lidocan VI is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.",
"Description": "Lidocan VI is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben."
},
{
"NDCCode": "59088-997-07",
"PackageDescription": "1 TUBE in 1 CARTON (59088-997-07) > 85 g in 1 TUBE",
"NDC11Code": "59088-0997-07",
"ProductNDC": "59088-997",
"ProductTypeName": "HUMAN PRESCRIPTION DRUG",
"ProprietaryName": "Lidocaine Hcl",
"NonProprietaryName": "Lidocaine Hcl",
"DosageFormName": "CREAM",
"RouteName": "TOPICAL",
"StartMarketingDate": "20110613",
"MarketingCategoryName": "UNAPPROVED DRUG OTHER",
"LabelerName": "PureTek Corporation",
"SubstanceName": "LIDOCAINE HYDROCHLORIDE",
"StrengthNumber": "30",
"StrengthUnit": "mg/g",
"Pharm_Classes": "Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]",
"Status": "Deprecated",
"LastUpdate": "2025-01-31",
"PackageNdcExcludeFlag": "N",
"ProductNdcExcludeFlag": "N",
"ListingRecordCertifiedThrough": "20251231",
"StartMarketingDatePackage": "20110613",
"SamplePackage": "N",
"IndicationAndUsage": "Indications: For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.",
"Description": "Contains lidocaine HCl 3% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl). INGREDIENTS: Each gram of PharmaPure Rx Lidocaine HCl 3% Cream contains Lidocaine HCl USP 3%, Inactive ingredients include: Aluminum Sulfate, Calcium Acetate, Cetyl Alcohol, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Purified Water, Sodium Hydroxide, Sorbitan Stearate, Stearic Acid, Stearyl Alcohol."
}
]
}
<?xml version="1.0" encoding="utf-8"?>
<NDCList>
<NDC>
<NDCCode>59088-413-31</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE (59088-413-31) </PackageDescription>
<NDC11Code>59088-0413-31</NDC11Code>
<ProductNDC>59088-413</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing With Lavender Oil</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200605</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M014</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-413-06</NDCCode>
<PackageDescription>1 BOTTLE in 1 KIT (59088-413-06) / 710 mL in 1 BOTTLE (59088-413-39) </PackageDescription>
<NDC11Code>59088-0413-06</NDC11Code>
<ProductNDC>59088-413</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing With Lavender Oil</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200605</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M014</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-413-36</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-413-36) / 1 BOTTLE in 1 KIT (59088-413-14) / 118 mL in 1 BOTTLE (59088-413-08) </PackageDescription>
<NDC11Code>59088-0413-36</NDC11Code>
<ProductNDC>59088-413</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing With Lavender Oil</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200605</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M014</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200605</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>■ Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>31722-413-31</NDCCode>
<PackageDescription>5 CAPSULE in 1 BOTTLE (31722-413-31) </PackageDescription>
<NDC11Code>31722-0413-31</NDC11Code>
<ProductNDC>31722-413</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Temozolomide</ProprietaryName>
<NonProprietaryName>Temozolomide</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240823</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA210030</ApplicationNumber>
<LabelerName>Camber Pharmaceuticals, Inc.</LabelerName>
<SubstanceName>TEMOZOLOMIDE</SubstanceName>
<StrengthNumber>100</StrengthNumber>
<StrengthUnit>mg/1</StrengthUnit>
<Pharm_Classes>Alkylating Activity [MoA], Alkylating Drug [EPC]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2024-10-22</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240823</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Temozolomide capsule is an alkylating drug indicated for the treatment of adults with: Newly diagnosed glioblastoma concomitantly with radiotherapy and then as maintenance treatment. ( 1.1) Anaplastic astrocytoma. ( 1.2) o Adjuvant treatment of adults with newly diagnosed anaplastic astrocytoma. ( 1.2) o Treatment of adults with refractory anaplastic astrocytoma. ( 1.2).</IndicationAndUsage>
<Description>Temozolomide is an alkylating drug. The chemical name of temozolomide is 3,4-dihydro-3-methyl-4-oxoimidazo[5,1-d]- as-tetrazine-8-carboxamide. The structural formula of temozolomide is:. The material is a white to light pink or light tan powder with a molecular formula of C 6H 6N 6O 2and a molecular weight of 194.15. The molecule is stable at acidic pH (<5) and labile at pH >7; hence temozolomide capsules can be administered orally. The prodrug, temozolomide, is rapidly hydrolyzed to the active 5-(3-methyltriazen-1-yl) imidazole-4-carboxamide (MTIC) at neutral and alkaline pH values, with hydrolysis taking place even faster at alkaline pH. Temozolomide capsules, USP for oral use contains either 5 mg, 20 mg, 100 mg, 140 mg, 180 mg, or 250 mg of temozolomide, USP. The inactive ingredients are anhydrous lactose, colloidal silica, sodium starch glycolate, stearic acid, tartaric acid. The body of the capsules is made of gelatin and is opaque white. The cap is also made of gelatin, and the colors vary based on the dosage strength. The capsule body and cap are imprinted with pharmaceutical branding ink, which contains black iron oxide, dehydrated alcohol, isopropyl alcohol, potassium hydroxide, propylene glycol, shellac, and strong ammonia solution. Temazolomide Capsules USP, 5 mg:The opaque green cap contains FD&C Blue #2, gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 20 mg:The opaque yellow cap contains gelatin, iron oxide yellow, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsule USP, 100 mg:The opaque pink cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules, USP, 140 mg:The opaque blue cap contains FD&C Blue #2, gelatin, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 180 mg:The opaque orange cap contains gelatin, iron oxide red, sodium lauryl sulfate, and titanium dioxide. Temazolomide Capsules USP, 250 mg:The opaque white cap contains gelatin, sodium lauryl sulfate, and titanium dioxide.</Description>
</NDC>
<NDC>
<NDCCode>43419-413-31</NDCCode>
<PackageDescription>2 CONTAINER in 1 CARTON (43419-413-31) > 15 g in 1 CONTAINER</PackageDescription>
<NDC11Code>43419-0413-31</NDC11Code>
<ProductNDC>43419-413</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Iope Air Cushion Intense Cover 23</ProprietaryName>
<NonProprietaryName>Zinc Oxide, Octinoxate, And Titanium Dioxide</NonProprietaryName>
<DosageFormName>LOTION</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20180102</StartMarketingDate>
<EndMarketingDate>20201231</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part352</ApplicationNumber>
<LabelerName>AMOREPACIFIC CORPORATION</LabelerName>
<SubstanceName>ZINC OXIDE; OCTINOXATE; TITANIUM DIOXIDE</SubstanceName>
<StrengthNumber>1.47; 1.05; .6225</StrengthNumber>
<StrengthUnit>g/15g; g/15g; g/15g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2021-01-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20180102</StartMarketingDatePackage>
<EndMarketingDatePackage>20201231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>66129-413-31</NDCCode>
<PackageDescription>50 g in 1 TUBE (66129-413-31)</PackageDescription>
<NDC11Code>66129-0413-31</NDC11Code>
<ProductNDC>66129-413</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Idole Natural Organic Skin Lightening</ProprietaryName>
<NonProprietaryName>Hydroquinone</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110101</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part358A</ApplicationNumber>
<LabelerName>International Beauty Exchange</LabelerName>
<SubstanceName>HYDROQUINONE; OCTINOXATE</SubstanceName>
<StrengthNumber>1; .25</StrengthNumber>
<StrengthUnit>g/50g; g/50g</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2019-09-21</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20171231</ListingRecordCertifiedThrough>
<IndicationAndUsage>For the gradual fading of dark (brownish) areas in the skin such as freckles, age and liver spots.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-201-31</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (59088-201-31) </PackageDescription>
<NDC11Code>59088-0201-31</NDC11Code>
<ProductNDC>59088-201</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Liquical Plus</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20240612</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHOLECALCIFEROL; ZINC CITRATE; MAGNESIUM CITRATE; CALCIUM CITRATE</SubstanceName>
<StrengthNumber>1200; 2.1; 72; 252</StrengthNumber>
<StrengthUnit>[iU]/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240612</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LiquiCal Plus is indicated for dietary management of patients with unique nutritional needs requiring increased Vitamin D3 and essential minerals, including Calcium, Magnesium, and Zinc in a convenient liquid form for easy administration.</IndicationAndUsage>
<Description>LiquiCal Plus Rx Only Full Prescribing Information. Active Ingredients: Each 5 mL Contains: Vitamin D3 (as Cholecalciferol) ................................................................. 10 mcg (400 IU) Calcium (as Calcium Citrate) ..................................................................................... 84 mg Magnesium (as Magnesium Citrate) ......................................................................... 24 mg Zinc (as Zinc Citrate) ................................................................................................ 0.7 mg. Each 15 mL Contains: Vitamin D3 (as Cholecalciferol) ............................................................... 30 mcg (1200 IU) Calcium (as Calcium Citrate) ................................................................................... 252 mg Magnesium (as Magnesium Citrate) ......................................................................... 72 mg Zinc (as Zinc Citrate) ................................................................................................ 2.1 mg. Other Ingredients: Agave Tequilana (Tequila Agave) Stem Extract, Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum.</Description>
</NDC>
<NDC>
<NDCCode>59088-299-31</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE, DISPENSING (59088-299-31) </PackageDescription>
<NDC11Code>59088-0299-31</NDC11Code>
<ProductNDC>59088-299</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Genrx Anti-bacterial Gel</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200318</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH DRUG</MarketingCategoryName>
<ApplicationNumber>M014</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2024-10-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200318</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Hand sanitizer to help reduce bacteria on the skin.</IndicationAndUsage>
</NDC>
<NDC>
<NDCCode>59088-332-31</NDCCode>
<PackageDescription>500 mL in 1 BOTTLE, PUMP (59088-332-31) </PackageDescription>
<NDC11Code>59088-0332-31</NDC11Code>
<ProductNDC>59088-332</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200424</StartMarketingDate>
<EndMarketingDate>20220531</EndMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2022-06-01</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<StartMarketingDatePackage>20200424</StartMarketingDatePackage>
<EndMarketingDatePackage>20220531</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-370-31</NDCCode>
<PackageDescription>473 mL in 1 BOTTLE (59088-370-31) </PackageDescription>
<NDC11Code>59088-0370-31</NDC11Code>
<ProductNDC>59088-370</ProductNDC>
<ProductTypeName>HUMAN OTC DRUG</ProductTypeName>
<ProprietaryName>Hand Sanitizing</ProprietaryName>
<NonProprietaryName>Alcohol</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200515</StartMarketingDate>
<MarketingCategoryName>OTC MONOGRAPH NOT FINAL</MarketingCategoryName>
<ApplicationNumber>part333A</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>ALCOHOL</SubstanceName>
<StrengthNumber>62</StrengthNumber>
<StrengthUnit>mL/100mL</StrengthUnit>
<Status>Deprecated</Status>
<LastUpdate>2020-07-02</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20211231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200515</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-659-31</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (59088-659-31) </PackageDescription>
<NDC11Code>59088-0659-31</NDC11Code>
<ProductNDC>59088-659</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Livita Adults</ProprietaryName>
<NonProprietaryName>Folate, Multivitamin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231215</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHOLINE BITARTRATE; CHOLECALCIFEROL; VITAMIN A ACETATE; ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; ZINC PICOLINATE; MAGNESIUM CITRATE; CALCIUM PANTOTHENATE; CALCIUM CITRATE; INULIN</SubstanceName>
<StrengthNumber>200; 10; 900; 200; 30; 1.2; 1.3; 8; 1.7; 1000; 2.4; 30; 2; 100; 5; 200; 500</StrengthNumber>
<StrengthUnit>mg/15mL; ug/15mL; ug/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; ug/15mL; ug/15mL; ug/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL; mg/15mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231215</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Livita liquid is indicated to provide significant amounts of essential vitamins and minerals, including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, folate, calcium, magnesium, and zinc, to supplement the diet. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs of adults and children are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps in adults, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.</IndicationAndUsage>
<Description>Active Ingredients: Amount Per Serving:. Vitamin A (as Retinyl Acetate).................................... 900 mcg RAE Vitamin C (as Ascorbic Acid)............................................... 200 mg Vitamin D3 (as Cholecalciferol)............................................ 10 mcg Vitamin E (as D-Alpha Tocopheryl Acetate)............................ 30 mg Thiamin (as Thiamine Mononitrate)...................................... 1.2 mg Riboflavin ............................................................................. 1.3 mg Niacin (as Niacinamide)........................................................... 8 mg Vitamin B6 (as Pyridoxine Hydrochloride)............................ 1.7 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)...1700 mcg DFE (1000 mcg of L-5-Methylfolate) Vitamin B12 (as Methylcobalamin and Hydroxocobalamin)...2.4 mcg Biotin (as D-Biotin)............................................................... 30 mcg Pantothenic Acid (as D-Calcium Pantothenate)........................ 5 mg Choline (as Choline Bitartrate)............................................. 200 mg Calcium (as Calcium Citrate)................................................ 200 mg Magnesium (as Magnesium Citrate).................................... 100 mg Zinc (as Zinc Picolinate)........................................................... 2 mg Inulin (as Helianthus Tuberosus Root Extract)..................... 500 mg. Other Ingredients: Aqua (Water), Organic Agave Syrup, Carrageenan, Citrus Extract, Flavor, Glycerin, Hydroxocobalamin Acetate, Potassium Sorbate, Organic Stevia Rebaudiana Leaf Extract.</Description>
</NDC>
<NDC>
<NDCCode>59088-723-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-723-00) * 100 CAPSULE in 1 BOTTLE (62332-141-31) * 59 mL in 1 BOTTLE, SPRAY (GS1:7-31477-27221-7) </PackageDescription>
<NDC11Code>59088-0723-00</NDC11Code>
<ProductNDC>59088-723</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Celexib 100-ezs</ProprietaryName>
<NonProprietaryName>Celecoxib</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20181022</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA204519</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-04-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20191231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20181022</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-786-31</NDCCode>
<PackageDescription>480 mL in 1 BOTTLE (59088-786-31) </PackageDescription>
<NDC11Code>59088-0786-31</NDC11Code>
<ProductNDC>59088-786</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Liquical With Magnesium</ProprietaryName>
<NonProprietaryName>Multivitamin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231227</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CALCIUM CITRATE; CHOLECALCIFEROL; MAGNESIUM CITRATE; ZINC CITRATE</SubstanceName>
<StrengthNumber>168; 66; 48; 1.4</StrengthNumber>
<StrengthUnit>mg/mL; [iU]/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2024-04-03</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231227</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LiquiCal with Magnesium is indicated to provide support in children's healthy bone growth and development.</IndicationAndUsage>
<Description>Vitamin D3 (Cholecalciferol): Vitamin D3 plays a pivotal role in maintaining bone health and may also help mitigate mood disturbances. It is recommended to seek a supplement offering 600-800 IU of Vitamin D3 daily, although personal dosing should be discussed with a licensed healthcare practitioner. Calcium (Calcium Citrate): Calcium is a key mineral that fortifies bones, particularly crucial during menopause due to heightened osteoporosis risks. Women over 50 typically require around 1000-1300 mg of calcium daily, although intake should be calibrated based on diet. Magnesium (Magnesium Citrate): Magnesium offers relief from muscle cramps, mood fluctuations, and sleep disturbances. Zinc Citrate: Zinc is an essential trace element that has a critical role in maintaining structural and catalytic functions of >200 enzymes involved in major metabolic pathways, including nucleic acid metabolism, protein synthesis, and cell division. OTHER INGREDIENTS: Aqua (Purified Water), Citric Acid, Orange Flavor, Potassium Sorbate, Xanthan Gum, Xylitol.</Description>
</NDC>
<NDC>
<NDCCode>59088-083-00</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (59088-083-00) * 9 BLISTER PACK in 1 CARTON (55111-292-09) / 9 TABLET in 1 BLISTER PACK * 85 g in 1 BOTTLE, WITH APPLICATOR (59088-283-07) </PackageDescription>
<NDC11Code>59088-0083-00</NDC11Code>
<ProductNDC>59088-083</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Migranow</ProprietaryName>
<NonProprietaryName>Sumatriptan Succinate, Camphor, Menthol</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160418</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Active</Status>
<LastUpdate>2024-12-17</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20160418</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Sumatriptan tablets are indicated for the acute treatment of migraine attacks with or without aura in adults. Sumatriptan tablets are not intended for the prophylactic therapy of migraine or for use in the management of hemiplegic or basilar migraine (see CONTRAINDICATIONS). Safety and effectiveness of sumatriptan tablets have not been established for cluster headache, which is present in an older, predominantly male population.</IndicationAndUsage>
<Description>Sumatriptan tablets USP contain sumatriptan (as the succinate), a selective 5-hydroxytryptamine 1 receptor subtype agonist. Sumatriptan succinate USP is chemically designated as 3-[2- (dimethylamino) ethyl]-N-methyl-indole-5-methanesulfonamide succinate (1:1), and it has the following structure:. The molecular formula is C 14H 21N 3O 2SC 4H 6O 4, representing a molecular weight of 413.5. Sumatriptan succinate USP is a white to off-white powder that is readily soluble in water and in saline. Each sumatriptan tablet USP for oral administration contains 35, 70, or 140 mg of sumatriptan succinate USP equivalent to 25, 50, or 100 mg of sumatriptan, respectively. Each tablet also contains the inactive ingredients croscarmellose sodium, lactose anhydrous, lactose monohydrate, magnesium stearate, mannitol, microcrystalline cellulose, talc, titanium dioxide and triacetin.</Description>
</NDC>
<NDC>
<NDCCode>59088-113-66</NDCCode>
<PackageDescription>90 CAPSULE in 1 BOTTLE, PLASTIC (59088-113-66)</PackageDescription>
<NDC11Code>59088-0113-66</NDC11Code>
<ProductNDC>59088-113</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Purefe Ob Plus</ProprietaryName>
<NonProprietaryName>Ferrous Fumarate And Polysaccharide Iron Complex</NonProprietaryName>
<DosageFormName>CAPSULE</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>FERROUS FUMARATE; IRON DEXTRAN; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; FOLIC ACID; CYANOCOBALAMIN; CALCIUM PANTOTHENATE; SODIUM ASCORBATE; THIAMINE MONONITRATE; MAGNESIUM SULFATE, UNSPECIFIED; ZINC SULFATE; CUPRIC SULFATE; MANGANESE SULFATE</SubstanceName>
<StrengthNumber>53; 53; 6; 30; 5; 1; 15; 10; 200; 10; 6.9; 18.2; .8; 1.3</StrengthNumber>
<StrengthUnit>mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; ug/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1; mg/1</StrengthUnit>
<Pharm_Classes>Nicotinic Acid [EPC],Nicotinic Acids [CS],Vitamin B6 Analog [EPC],Vitamin B 6 [Chemical/Ingredient],Analogs/Derivatives [Chemical/Ingredient],Vitamin B 12 [CS],Vitamin B12 [EPC],Vitamin C [EPC],Ascorbic Acid [CS],Copper [CS],Copper-containing Intrauterine Device [EPC],Decreased Embryonic Implantation [PE],Decreased Sperm Motility [PE],Inhibit Ovum Fertilization [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2019-05-31</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59088-115-60</NDCCode>
<PackageDescription>6 BLISTER PACK in 1 CARTON (59088-115-60) > 1 KIT in 1 BLISTER PACK</PackageDescription>
<NDC11Code>59088-0115-60</NDC11Code>
<ProductNDC>59088-115</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Pnv Ob Dha</ProprietaryName>
<NonProprietaryName>Vitamin C, Calcium, Iron, Vitamin D3, Vitamin E, Vitamin B1, Vitamin B2, Vitamin B3, Vitamin B6, Folic Acid, Iodine, Zinc, Copper, Docusate Sodium, Docosahexaenoic Acid (dha)</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20110601</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-05-31</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59088-210-16</NDCCode>
<PackageDescription>227 g in 1 JAR (59088-210-16) </PackageDescription>
<NDC11Code>59088-0210-16</NDC11Code>
<ProductNDC>59088-210</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Urea 39.5% With 2% Salicylic Acid</ProprietaryName>
<NonProprietaryName>Urea, Salicylic Acid</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230324</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>UREA; SALICYLIC ACID</SubstanceName>
<StrengthNumber>39.5; 2</StrengthNumber>
<StrengthUnit>g/100g; g/100g</StrengthUnit>
<Status>Active</Status>
<LastUpdate>2023-03-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230324</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, soothes rough and dry skin, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.</IndicationAndUsage>
<Description>Urea 39.5% Cream with 2% Salicylic Acid is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin space. Each gram contains 395 mg of urea, 20 mg of Salicylic Acid in vehicle consisting of: Aqua (Purified Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylparaben, Simethicone, Sodium Hydroxide, Squalane, Stearic Acid. Urea is a diamide of carbonic acid with the following chemical structure.</Description>
</NDC>
<NDC>
<NDCCode>59088-378-00</NDCCode>
<PackageDescription>1 KIT in 1 PACKAGE (59088-378-00) * 5 g in 1 TUBE (0168-0357-05) * 1 in 1 BAG (GS1:19555240400625)</PackageDescription>
<NDC11Code>59088-0378-00</NDC11Code>
<ProductNDC>59088-378</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Venipuncture Cpi</ProprietaryName>
<NonProprietaryName>Lidocaine And Prilocaine</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20160509</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA076453</ApplicationNumber>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2019-05-31</LastUpdate>
<ProductNdcExcludeFlag>E</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20181231</ListingRecordCertifiedThrough>
</NDC>
<NDC>
<NDCCode>59088-660-16</NDCCode>
<PackageDescription>237 mL in 1 BOTTLE (59088-660-16) </PackageDescription>
<NDC11Code>59088-0660-16</NDC11Code>
<ProductNDC>59088-660</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Livita Children</ProprietaryName>
<NonProprietaryName>Folate, Multivitamin</NonProprietaryName>
<DosageFormName>LIQUID</DosageFormName>
<RouteName>ORAL</RouteName>
<StartMarketingDate>20231218</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>CHOLINE BITARTRATE; CHOLECALCIFEROL; VITAMIN A ACETATE; ASCORBIC ACID; .ALPHA.-TOCOPHEROL ACETATE, D-; THIAMINE MONONITRATE; RIBOFLAVIN; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; LEVOMEFOLATE CALCIUM; METHYLCOBALAMIN; BIOTIN; ZINC PICOLINATE; MAGNESIUM CITRATE; CALCIUM PANTOTHENATE; CALCIUM CITRATE; INULIN</SubstanceName>
<StrengthNumber>66.67; 3.33; 300; 66.67; 10; .4; .43; 2.67; .57; 333; .8; 10; .67; 33.33; 1.67; 66.67; 166.67</StrengthNumber>
<StrengthUnit>mg/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL; ug/mL; ug/mL; ug/mL; mg/mL; mg/mL; mg/mL; mg/mL; mg/mL</StrengthUnit>
<Pharm_Classes>Analogs/Derivatives [Chemical/Ingredient], Ascorbic Acid [CS], Blood Coagulation Factor [EPC], Calcium [CS], Calculi Dissolution Agent [EPC], Cations, Divalent [CS], Copper Absorption Inhibitor [EPC], Decreased Copper Ion Absorption [PE], Folate Analog [EPC], Folic Acid [CS], Increased Coagulation Factor Activity [PE], Increased Large Intestinal Motility [PE], Inhibition Large Intestine Fluid/Electrolyte Absorption [PE], Inhibition Small Intestine Fluid/Electrolyte Absorption [PE], Magnesium Ion Exchange Activity [MoA], Osmotic Activity [MoA], Osmotic Laxative [EPC], Phosphate Binder [EPC], Phosphate Chelating Activity [MoA], Stimulation Large Intestine Fluid/Electrolyte Secretion [PE], Vitamin A [CS], Vitamin A [EPC], Vitamin B 6 [Chemical/Ingredient], Vitamin B6 Analog [EPC], Vitamin C [EPC], Vitamin D [CS], Vitamin D [EPC]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2026-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20231218</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Livita liquid is indicated to provide significant amounts of essential vitamins and minerals, including Vitamins A, C, D, E, thiamine, riboflavin, niacin, vitamin B6, vitamin B12, folate, calcium, magnesium, and zinc, to supplement the diet. This comprehensive nutrient profile helps prevent nutritional deficiencies of these vitamins and minerals, ensuring that the specific dietary needs of adults and children are met to support overall health, energy, and vitality. The product is specially formulated to target common vitamin and mineral gaps in adults, thus promoting optimal health, immune function, bone strength, and metabolic balance. It is intended to be used under the guidance of a licensed healthcare practitioner to ensure that any potential for nutritional deficiency is addressed in a manner that supports the individual's overall health and wellbeing.</IndicationAndUsage>
<Description>Serving Size: 15 mL Servings per container: 47. Vitamin A (as Retinyl Acetate)........................ 300 mcg RAE Vitamin C (as Ascorbic Acid)............................... 66.67 mg Vitamin D3 (as Cholecalciferol)............................ 3.33 mcg Vitamin E (as D-Alpha Tocopheryl Acetate)............. 10 mg Thiamin (as Thiamine Mononitrate)......................... 0.4 mg Riboflavin .............................................................. 0.43 mg Niacin (as Niacinamide)......................................... 2.67 mg Vitamin B6 (as Pyridoxine Hydrochloride)............. 0.57 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)...566 mcg DFE (333 mcg of L-5-Methylfolate) Vitamin B12 (as Methylcobalamin)......................... 0.8 mcg Biotin (as D-Biotin)................................................. 10 mcg Pantothenic Acid (as D-Calcium Pantothenate)..... 1.67 mg Choline (as Choline Bitartrate)............................. 66.67 mg Calcium (as Calcium Citrate)............................... 66.67 mg Magnesium (as Magnesium Citrate)...................... 33.3 mg Zinc (as Zinc Picolinate)........................................ 0.67 mg Inulin (as Helianthus Tuberosus Root Extract)... 166.67 mg. Other Ingredients: Aqua (Water), Organic Agave Syrup, Carrageenan, Citrus Extract, Flavor, Glycerin, Hydroxocobalamin Acetate, Potassium Sorbate, Organic Stevia Rebaudiana Leaf Extract.</Description>
</NDC>
<NDC>
<NDCCode>59088-771-07</NDCCode>
<PackageDescription>7 g in 1 TUBE (59088-771-07) </PackageDescription>
<NDC11Code>59088-0771-07</NDC11Code>
<ProductNDC>59088-771</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>30; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula. NGREDIENTS: PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 1% CreamEach gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 10 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 3% HYDROCORTISONE ACETATE 1%.</Description>
</NDC>
<NDC>
<NDCCode>59088-771-20</NDCCode>
<PackageDescription>20 TUBE in 1 KIT (59088-771-20) / 7 g in 1 TUBE (59088-771-01) </PackageDescription>
<NDC11Code>59088-0771-20</NDC11Code>
<ProductNDC>59088-771</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>30; 10</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-05-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<EndMarketingDatePackage>20250530</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula. NGREDIENTS: PharmaPure Rx Lidocaine HCl 3% - Hydrocortisone Acetate 1% CreamEach gram contains Lidocaine HCl 30 mg, Hydrocortisone Acetate 10 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 3% HYDROCORTISONE ACETATE 1%.</Description>
</NDC>
<NDC>
<NDCCode>59088-798-00</NDCCode>
<PackageDescription>1 KIT in 1 KIT (59088-798-00) * 1 BOTTLE, DROPPER in 1 CARTON (51672-1358-2) / 150 mL in 1 BOTTLE, DROPPER * 237 mL in 1 BOTTLE, PUMP (59088-310-16) </PackageDescription>
<NDC11Code>59088-0798-00</NDC11Code>
<ProductNDC>59088-798</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lextol</ProprietaryName>
<NonProprietaryName>Diclofenac Sodium, Capsaicin</NonProprietaryName>
<DosageFormName>KIT</DosageFormName>
<StartMarketingDate>20230825</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<Status>Deprecated</Status>
<LastUpdate>2023-08-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20241231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20230825</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
</NDC>
<NDC>
<NDCCode>59088-816-01</NDCCode>
<PackageDescription>7 g in 1 TUBE (59088-816-01) </PackageDescription>
<NDC11Code>59088-0816-01</NDC11Code>
<ProductNDC>59088-816</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>20; 20</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure: Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. INGREDIENTS: PharmaPure Rx Lidocaine HCl 2% - Hydrocortisone Acetate 2% Cream. Each gram contains Lidocaine HCl 20 mg, Hydrocortisone Acetate 20 mg. ACTIVE INGREDIENTS. LIDOCAINE HCl 2% HYDROCORTISONE ACETATE 2%.</Description>
</NDC>
<NDC>
<NDCCode>59088-817-01</NDCCode>
<PackageDescription>1 TUBE in 1 KIT (59088-817-01) / 100 g in 1 TUBE (59088-817-07) </PackageDescription>
<NDC11Code>59088-0817-01</NDC11Code>
<ProductNDC>59088-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<ProprietaryNameSuffix>With Aloe</ProprietaryNameSuffix>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>28; 5.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<EndMarketingDatePackage>20261231</EndMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55%.</Description>
</NDC>
<NDC>
<NDCCode>59088-817-07</NDCCode>
<PackageDescription>100 g in 1 TUBE (59088-817-07) </PackageDescription>
<NDC11Code>59088-0817-07</NDC11Code>
<ProductNDC>59088-817</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl - Hydrocortisone Acetate</ProprietaryName>
<ProprietaryNameSuffix>With Aloe</ProprietaryNameSuffix>
<NonProprietaryName>Lidocaine Hcl And Hydrocortisone Acetate</NonProprietaryName>
<DosageFormName>GEL</DosageFormName>
<RouteName>RECTAL</RouteName>
<StartMarketingDate>20110701</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE; HYDROCORTISONE ACETATE</SubstanceName>
<StrengthNumber>28; 5.5</StrengthNumber>
<StrengthUnit>mg/g; mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Corticosteroid Hormone Receptor Agonists [MoA], Corticosteroid [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110701</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Product is used for the anti-inflammatory and anesthetic relief of itching, pain, soreness and discomfort due to hemorrhoids, anal fissures, pruritus ani and similar conditions of the anal area.</IndicationAndUsage>
<Description>Anti-Inflammatory Anesthetic for Relief of Hemorrhoid Pain, Swelling and Inflammation.Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), and has the following structure:. Hydrocortisone acetate has a chemical name pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-(11β)-, and has the following structural formula:. NGREDIENTS: PharmaPure Rx Lidocaine HCl 2.8% - Hydrocortisone Acetate 0.55% Gel with Aloe Each gram contains Lidocaine HCl 28 mg, Hydrocortisone Acetate 5.5 mg. ACTIVE INGREDIENTS: LIDOCAINE HCl 2.8% HYDROCORTISONE ACETATE 0.55%.</Description>
</NDC>
<NDC>
<NDCCode>59088-900-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-900-54) / 14 g in 1 POUCH (59088-900-84) </PackageDescription>
<NDC11Code>59088-0900-54</NDC11Code>
<ProductNDC>59088-900</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan Vii</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240808</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocan VII is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocan VII is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59088-907-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-907-54) / 14 g in 1 POUCH (59088-907-84) </PackageDescription>
<NDC11Code>59088-0907-54</NDC11Code>
<ProductNDC>59088-907</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan Iii</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>LIDOCAN III is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>LIDOCAN III is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59088-909-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-909-54) / 14 g in 1 POUCH (59088-909-84) </PackageDescription>
<NDC11Code>59088-0909-54</NDC11Code>
<ProductNDC>59088-909</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan V</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20200514</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20200514</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocan V is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocan V is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59088-911-54</NDCCode>
<PackageDescription>30 POUCH in 1 PACKAGE (59088-911-54) / 14 g in 1 POUCH (59088-911-84) </PackageDescription>
<NDC11Code>59088-0911-54</NDC11Code>
<ProductNDC>59088-911</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocan Vi</ProprietaryName>
<NonProprietaryName>Lidocaine 5%</NonProprietaryName>
<DosageFormName>PATCH</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20230615</StartMarketingDate>
<MarketingCategoryName>ANDA</MarketingCategoryName>
<ApplicationNumber>ANDA209190</ApplicationNumber>
<LabelerName>PURETEK CORPORATION</LabelerName>
<SubstanceName>LIDOCAINE</SubstanceName>
<StrengthNumber>50</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Active</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20261231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20240621</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Lidocan VI is indicated for relief of pain associated with post-herpetic neuralgia. It should be applied only to intact skin.</IndicationAndUsage>
<Description>Lidocan VI is comprised of an adhesive material containing 5% lidocaine, which is applied to a non-woven polyester felt backing and covered with a polyethylene terephthalate (PET) film release liner. The release liner is removed prior to application to the skin. The size of the patch is 10 cm x 14 cm. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl), has an octanol:water partition ratio of 43 at pH 7.4, and has the following structure:. Each adhesive patch contains 700 mg of lidocaine (50 mg per gram adhesive) in an aqueous base. It also contains the following inactive ingredients: purified water, glycerin, sorbitol, polyacrylic acid, sodium carboxymethylcellulose, sodium polyacrylate, propylene glycol, urea, kaolin, tartaric acid, gelatin, polyvinyl alcohol, dihydroxyaluminum aminoacetate, edetate disodium, methylparaben, and propylparaben.</Description>
</NDC>
<NDC>
<NDCCode>59088-997-07</NDCCode>
<PackageDescription>1 TUBE in 1 CARTON (59088-997-07) > 85 g in 1 TUBE</PackageDescription>
<NDC11Code>59088-0997-07</NDC11Code>
<ProductNDC>59088-997</ProductNDC>
<ProductTypeName>HUMAN PRESCRIPTION DRUG</ProductTypeName>
<ProprietaryName>Lidocaine Hcl</ProprietaryName>
<NonProprietaryName>Lidocaine Hcl</NonProprietaryName>
<DosageFormName>CREAM</DosageFormName>
<RouteName>TOPICAL</RouteName>
<StartMarketingDate>20110613</StartMarketingDate>
<MarketingCategoryName>UNAPPROVED DRUG OTHER</MarketingCategoryName>
<LabelerName>PureTek Corporation</LabelerName>
<SubstanceName>LIDOCAINE HYDROCHLORIDE</SubstanceName>
<StrengthNumber>30</StrengthNumber>
<StrengthUnit>mg/g</StrengthUnit>
<Pharm_Classes>Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Local Anesthesia [PE]</Pharm_Classes>
<Status>Deprecated</Status>
<LastUpdate>2025-01-31</LastUpdate>
<PackageNdcExcludeFlag>N</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>N</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>20251231</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>20110613</StartMarketingDatePackage>
<SamplePackage>N</SamplePackage>
<IndicationAndUsage>Indications: For the temporary relief of pain and itching associated with minor burns, sunburn, minor cuts, scrapes, insect bites, and minor skin irritation.</IndicationAndUsage>
<Description>Contains lidocaine HCl 3% in a mild acidic vehicle. Lidocaine is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl). INGREDIENTS: Each gram of PharmaPure Rx Lidocaine HCl 3% Cream contains Lidocaine HCl USP 3%, Inactive ingredients include: Aluminum Sulfate, Calcium Acetate, Cetyl Alcohol, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Propylparaben, Purified Water, Sodium Hydroxide, Sorbitan Stearate, Stearic Acid, Stearyl Alcohol.</Description>
</NDC>
</NDCList>