<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
70983-029-01
</NDCCode>
<PackageDescription>
1 TUBE in 1 BOX (70983-029-01) / 13 g in 1 TUBE
</PackageDescription>
<NDC11Code>
70983-0029-01
</NDC11Code>
<ProductNDC>
70983-029
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Dermedial Anti-itch
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Oatmeal, Zinc Oxide
</NonProprietaryName>
<DosageFormName>
OINTMENT
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20250704
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M016
</ApplicationNumber>
<LabelerName>
Saje Natural Business Inc
</LabelerName>
<SubstanceName>
OATMEAL; ZINC OXIDE
</SubstanceName>
<StrengthNumber>
1.3871; .416
</StrengthNumber>
<StrengthUnit>
g/13g; g/13g
</StrengthUnit>
<Pharm_Classes>
Allergens [CS], Cell-mediated Immunity [PE], Dietary Proteins [CS], Grain Proteins [EXT], Increased Histamine Release [PE], Non-Standardized Food Allergenic Extract [EPC], Non-Standardized Plant Allergenic Extract [EPC], Plant Proteins [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-07-18
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20250704
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>