<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82018-0028-4
</NDCCode>
<PackageDescription>
102 g in 1 BOTTLE, PUMP (82018-0028-4)
</PackageDescription>
<NDC11Code>
82018-0028-04
</NDC11Code>
<ProductNDC>
82018-0028
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Balance Plus Cream
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Estriol,estradiol,progesterone,dhea
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TRANSDERMAL
</RouteName>
<StartMarketingDate>
20250601
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
SHYNE BRANDS/BIOLabs PRO
</LabelerName>
<SubstanceName>
ESTRADIOL; ESTRIOL; PRASTERONE; PROGESTERONE
</SubstanceName>
<StrengthNumber>
60; 240; 1000; 6000
</StrengthNumber>
<StrengthUnit>
mg/102g; mg/102g; mg/102g; mg/102g
</StrengthUnit>
<Pharm_Classes>
Estradiol Congeners [CS], Estrogen Receptor Agonists [MoA], Estrogen [EPC], Progesterone [CS], Progesterone [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-06-19
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250601
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>