Label: ALCOHOL FREE FOAM SANITIZER- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 54057-304-60 - Packager: Afflink, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
Drug Label Information
Updated December 13, 2012
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- Alcohol Free Foam Sanitizer
- Alcohol Free Foam Sanitizer
- Alcohol Free Foam Sanitizer
- Alcohol Free Foam Sanitizer
- Alcohol Free Foam Sanitizer
- Alcohol Free Foam Sanitizer
- Alcohol Free Foam Sanitizer
- Alcohol Free Foam Sanitizer
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INGREDIENTS AND APPEARANCE
ALCOHOL FREE FOAM SANITIZER
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54057-304 Route of Administration Topical Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.3 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) DIMETHICONE (UNII: 92RU3N3Y1O) DMDM HYDANTOIN (UNII: BYR0546TOW) PEG-6 COCAMIDE (UNII: YZ6NLA4O1E) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54057-304-60 1000 mL in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 11/12/2012 Labeler - Afflink, Inc. (023121150) Registrant - Betco corporation, Ltd. (005050158) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd. 005050158 manufacture(54057-304)