<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
71573-120-11
</NDCCode>
<PackageDescription>
90 mL in 1 BOTTLE, PLASTIC (71573-120-11)
</PackageDescription>
<NDC11Code>
71573-0120-11
</NDC11Code>
<ProductNDC>
71573-120
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Prosoria Anti-itch Moisturizer
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Pramoxine Hydrochloride
</NonProprietaryName>
<DosageFormName>
LOTION
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20220401
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M015
</ApplicationNumber>
<LabelerName>
Nuvothera, Inc.
</LabelerName>
<SubstanceName>
PRAMOXINE HYDROCHLORIDE
</SubstanceName>
<StrengthNumber>
.9
</StrengthNumber>
<StrengthUnit>
g/90mL
</StrengthUnit>
<Pharm_Classes/>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-01-15
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20220401
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>