Label: NORTH WOODS DERMA FOAM HAND SANITIZER- benzalkonium chloride soap
- NDC Code(s): 53125-700-54, 53125-700-57
- Packager: Superior Chemical Corporation
- 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 April 9, 2019
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- QUESTIONS
- PURPOSE
- KEEP OUT OF REACH OF CHILDREN
- Superior Derma Foam Hand Sanitizer
-
INGREDIENTS AND APPEARANCE
NORTH WOODS DERMA FOAM HAND SANITIZER
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53125-700 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-3 COCAMINE (UNII: KTM00873VC) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) D&C GREEN NO. 5 (UNII: 8J6RDU8L9X) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53125-700-57 550 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2015 2 NDC:53125-700-54 1000 mL in 1 BAG; Type 0: Not a Combination Product 10/01/2015 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 10/01/2015 Labeler - Superior Chemical Corporation (023335086) Registrant - Betco corporation, Ltd. (024492831) Establishment Name Address ID/FEI Business Operations Betco Corporation, Ltd. 024492831 manufacture(53125-700) , pack(53125-700) , label(53125-700)