<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85524-2602-2
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 BOX (85524-2602-2) / 42.5 g in 1 BOTTLE (85524-2602-1)
</PackageDescription>
<NDC11Code>
85524-2602-02
</NDC11Code>
<ProductNDC>
85524-2602
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Hemorrhoid And Fissure
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Glycerin 6%,lidocaine 4%,ectoin 0.12%
</NonProprietaryName>
<DosageFormName>
OINTMENT
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260119
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M015
</ApplicationNumber>
<LabelerName>
FlexiGo Inc
</LabelerName>
<SubstanceName>
ECTOIN; GLYCERIN; LIDOCAINE
</SubstanceName>
<StrengthNumber>
.0012; .06; .04
</StrengthNumber>
<StrengthUnit>
g/g; g/g; g/g
</StrengthUnit>
<Pharm_Classes>
Allergens [CS], Amide Local Anesthetic [EPC], Amides [CS], Antiarrhythmic [EPC], Cell-mediated Immunity [PE], Glycerol [CS], Increased Histamine Release [PE], Increased IgG Production [PE], Local Anesthesia [PE], Non-Standardized Chemical Allergen [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-01-19
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260119
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>