<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
85966-008-01
</NDCCode>
<PackageDescription>
120 g in 1 BOTTLE (85966-008-01)
</PackageDescription>
<NDC11Code>
85966-0008-01
</NDC11Code>
<ProductNDC>
85966-008
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Tea Tree Oil Antifungal Cream
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Zinc Undecylenate, Undecylenic Acid
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20251212
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M005
</ApplicationNumber>
<LabelerName>
GUANGZHOU SAWEILAN IMPORT & EXPORT TRADING CO., LTD
</LabelerName>
<SubstanceName>
UNDECYLENIC ACID; ZINC UNDECYLENATE
</SubstanceName>
<StrengthNumber>
.05; .2
</StrengthNumber>
<StrengthUnit>
g/g; g/g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-12-16
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20251212
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>