<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
82996-001-01
</NDCCode>
<PackageDescription>
.5 g in 1 POUCH (82996-001-01)
</PackageDescription>
<NDC11Code>
82996-0001-01
</NDC11Code>
<ProductNDC>
82996-001
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
First Aid Antibiotic
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Bacitracin Zinc, Neomycin Sulfate, Polymyxin B Sulfate
</NonProprietaryName>
<DosageFormName>
GEL
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20221101
</StartMarketingDate>
<EndMarketingDate>
20270401
</EndMarketingDate>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M004
</ApplicationNumber>
<LabelerName>
Hubei Changjian Medical Products Co., Ltd.
</LabelerName>
<SubstanceName>
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
</SubstanceName>
<StrengthNumber>
400; 35; 5000
</StrengthNumber>
<StrengthUnit>
[iU]/g; mg/g; [iU]/g
</StrengthUnit>
<Pharm_Classes>
Aminoglycoside Antibacterial [EPC], Aminoglycosides [CS], Decreased Cell Wall Synthesis & Repair [PE], Polymyxin-class Antibacterial [EPC], Polymyxins [CS]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-10-15
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough/>
<StartMarketingDatePackage>
20221101
</StartMarketingDatePackage>
<EndMarketingDatePackage>
20270401
</EndMarketingDatePackage>
<SamplePackage>
N
</SamplePackage>
</NDC>