<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
59088-257-16
</NDCCode>
<PackageDescription>
227 g in 1 BOTTLE (59088-257-16)
</PackageDescription>
<NDC11Code>
59088-0257-16
</NDC11Code>
<ProductNDC>
59088-257
</ProductNDC>
<ProductTypeName>
HUMAN PRESCRIPTION DRUG
</ProductTypeName>
<ProprietaryName>
Uracin 20%
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Urea 20%
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260220
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
UNAPPROVED DRUG OTHER
</MarketingCategoryName>
<ApplicationNumber/>
<LabelerName>
PureTek Corporation
</LabelerName>
<SubstanceName>
UREA
</SubstanceName>
<StrengthNumber>
.2
</StrengthNumber>
<StrengthUnit>
g/g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-02-24
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260220
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>