Label: SIGNATURE ANTIBACTERIAL FOAMING HAND- benzalkonium chloride liquid
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Contains inactivated NDC Code(s)
NDC Code(s): 42961-011-05, 42961-011-06 - Packager: Cintas Corp.
- 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 March 31, 2015
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- ACTIVE INGREDIENT
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- INDICATIONS & USAGE
- WARNINGS
- DOSAGE & ADMINISTRATION
- INACTIVE INGREDIENT
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
SIGNATURE ANTIBACTERIAL FOAMING HAND
benzalkonium chloride liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-011 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE 1.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) BENZYL ALCOHOL (UNII: LKG8494WBH) PHENOXYETHANOL (UNII: HIE492ZZ3T) EDETATE SODIUM (UNII: MP1J8420LU) DEHYDROACETIC ACID (UNII: 2KAG279R6R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-011-05 500 mL in 1 BAG 2 NDC:42961-011-06 50 mL in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part333A 07/10/2014 Labeler - Cintas Corp. (056481716) Establishment Name Address ID/FEI Business Operations Best Sanitizers, Inc 627278224 manufacture(42961-011)
