<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
84847-540-00
</NDCCode>
<PackageDescription>
3 mL in 1 PACKET (84847-540-00)
</PackageDescription>
<NDC11Code>
84847-0540-00
</NDC11Code>
<ProductNDC>
84847-540
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Debachere Butt Balm After Care Antiseptic Pain Relief
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Benzocaine, Benzalkonium Chloride
</NonProprietaryName>
<DosageFormName>
CREAM
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20240927
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M017
</ApplicationNumber>
<LabelerName>
DE.BACHERE USA LLC
</LabelerName>
<SubstanceName>
BENZALKONIUM CHLORIDE; BENZOCAINE
</SubstanceName>
<StrengthNumber>
1; 50
</StrengthNumber>
<StrengthUnit>
mg/mL; mg/mL
</StrengthUnit>
<Pharm_Classes>
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-10-31
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20240927
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>