<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
53145-304-04
</NDCCode>
<PackageDescription>
7.5 g in 1 BOTTLE, PLASTIC (53145-304-04)
</PackageDescription>
<NDC11Code>
53145-0304-04
</NDC11Code>
<ProductNDC>
53145-304
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Polvos De Sulpha
</ProprietaryName>
<ProprietaryNameSuffix>
First Aid Antibiotic
</ProprietaryNameSuffix>
<NonProprietaryName>
Bacitracin Zinc, Polymyxin B Sulfate
</NonProprietaryName>
<DosageFormName>
POWDER
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20061211
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M004
</ApplicationNumber>
<LabelerName>
Menper Distributors Inc.
</LabelerName>
<SubstanceName>
BACITRACIN ZINC; POLYMYXIN B SULFATE
</SubstanceName>
<StrengthNumber>
500; 10000
</StrengthNumber>
<StrengthUnit>
[USP'U]/g; [USP'U]/g
</StrengthUnit>
<Pharm_Classes>
Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2025-01-17
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20061211
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>