<?xml version="1.0" encoding="UTF-8"?>
<NDC>
<NDCCode>
61010-5300-2
</NDCCode>
<PackageDescription>
90 g in 1 BOTTLE, SPRAY (61010-5300-2)
</PackageDescription>
<NDC11Code>
61010-5300-02
</NDC11Code>
<ProductNDC>
61010-5300
</ProductNDC>
<ProductTypeName>
HUMAN OTC DRUG
</ProductTypeName>
<ProprietaryName>
Antiseptic
</ProprietaryName>
<ProprietaryNameSuffix/>
<NonProprietaryName>
Benzalkonium Chloride, Benzocaine
</NonProprietaryName>
<DosageFormName>
SPRAY
</DosageFormName>
<RouteName>
TOPICAL
</RouteName>
<StartMarketingDate>
20120215
</StartMarketingDate>
<EndMarketingDate/>
<MarketingCategoryName>
OTC MONOGRAPH DRUG
</MarketingCategoryName>
<ApplicationNumber>
M003
</ApplicationNumber>
<LabelerName>
Safetec of America, Inc.
</LabelerName>
<SubstanceName>
BENZALKONIUM CHLORIDE; BENZOCAINE
</SubstanceName>
<StrengthNumber>
1; 50
</StrengthNumber>
<StrengthUnit>
mg/g; mg/g
</StrengthUnit>
<Pharm_Classes>
Allergens [CS], Cell-mediated Immunity [PE], Increased Histamine Release [PE], Standardized Chemical Allergen [EPC]
</Pharm_Classes>
<DEASchedule/>
<Status>
Active
</Status>
<LastUpdate>
2024-02-15
</LastUpdate>
<PackageNdcExcludeFlag>
N
</PackageNdcExcludeFlag>
<ProductNdcExcludeFlag>
N
</ProductNdcExcludeFlag>
<ListingRecordCertifiedThrough>
20261231
</ListingRecordCertifiedThrough>
<StartMarketingDatePackage>
20120215
</StartMarketingDatePackage>
<EndMarketingDatePackage/>
<SamplePackage>
N
</SamplePackage>
</NDC>