<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84989-025-01
</NDCCode>
<PackageDescription>
150 mg in 1 BOTTLE, PLASTIC (84989-025-01)
</PackageDescription>
<NDC11Code>
84989-0025-01
</NDC11Code>
<ProductNDC>
84989-025
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Putrizen 40 Urea
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Glycerin
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20260602
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M016
</ApplicationNumber>
<LabelerName>
Shantou Ximonth Biotechnology Co., Ltd.
</LabelerName>
<SubstanceName>
BUTYROSPERMUM PARKII (SHEA) BUTTER; MELALEUCA ALTERNIFOLIA (TEA TREE) LEAF OIL; SIMMONDSIA CHINENSIS (JOJOBA) SEED OIL
</SubstanceName>
<StrengthNumber>
12; .3; 7.5
</StrengthNumber>
<StrengthUnit>
mg/150mg; mg/150mg; mg/150mg
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2026-06-03
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20271231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20260602
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>