<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
68093-4503-1
</NDCCode>
<PackageDescription>
1 BOTTLE in 1 CARTON (68093-4503-1) > 22 g in 1 BOTTLE
</PackageDescription>
<NDC11Code>
68093-4503-01
</NDC11Code>
<ProductNDC>
68093-4503
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Ent Essentials Ear Wax Remvoer
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Carbamide Peroxide
</NonProprietaryName>
<DosageFormName>
LIQUID
</DosageFormName>
<RouteName>
AURICULAR (OTIC)
</RouteName>
<StartMarketingDate>
20170201
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH NOT FINAL
</MarketingCategoryName>
<ApplicationNumber>
part356
</ApplicationNumber>
<LabelerName>
Wisconsin Pharmacal Company
</LabelerName>
<SubstanceName>
CARBAMIDE PEROXIDE
</SubstanceName>
<StrengthNumber>
.065
</StrengthNumber>
<StrengthUnit>
g/g
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2017-12-07
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20170201
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>