Label: FOAM ANTIBACTERIAL HAND WASH- benzalkonium chloride soap
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Contains inactivated NDC Code(s)
NDC Code(s): 42961-953-01 - Packager: Cintas 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 December 29, 2022
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- PRINCIPAL DISPLAY PANEL - 500 mL Bag Label
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INGREDIENTS AND APPEARANCE
FOAM ANTIBACTERIAL HAND WASH
benzalkonium chloride soapProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:42961-953 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Benzalkonium Chloride (UNII: F5UM2KM3W7) (Benzalkonium - UNII:7N6JUD5X6Y) Benzalkonium Chloride 13 mg in 10 mL Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) Cetrimonium Chloride (UNII: UC9PE95IBP) Decylamine Oxide (UNII: G387VUT5EZ) Glycerin (UNII: PDC6A3C0OX) Coco Glucoside (UNII: ICS790225B) Laurtrimonium Chloride (UNII: A81MSI0FIC) Cocamidopropylamine Oxide (UNII: M4SL82J7HK) Citric Acid Monohydrate (UNII: 2968PHW8QP) Phenoxyethanol (UNII: HIE492ZZ3T) Tetrasodium Glutamate Diacetate (UNII: 5EHL50I4MY) Sodium Hydroxide (UNII: 55X04QC32I) Sodium Benzoate (UNII: OJ245FE5EU) Lactic Acid, Unspecified Form (UNII: 33X04XA5AT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:42961-953-01 500 mL in 1 BAG; Type 0: Not a Combination Product 02/03/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC MONOGRAPH NOT FINAL part333E 09/01/2017 Labeler - Cintas Corporation (056481716) Registrant - Rubbermaid Commercial Products LLC (049924368) Establishment Name Address ID/FEI Business Operations NWL Netherlands Production B.V. 489421698 manufacture(42961-953)