Label: AMAZON COMMERCIAL ANTIBACTERIAL FOAMING SKIN CLEANSER- benzalkonium chloride soap

  • 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 January 18, 2021

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  • Active Ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antibacterial

  • Warnings

    • For external use only. Do not ingest.
    • Avoid contact with eyes.  If contact occurs, rinse thoroughly with water.
    • Stop use and ask a doctor if irritation and redness develop.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.
    • If swallowed, get medical help or contact a Poison Control Center right away.
  • Directions

    • ?Read the entire label before using this product.
    • ?Dispense 2 pumps of product onto palm of hand and scrub thoroughly over all surfaces of both hands.
    • Rinse with clean water.
  • Inactive Ingredients

    Water, Lauramine Oxide, Decyl Glucoside, Propylene Glycol, PEG-4 Rapeseedamine, Cocamidopropyl Hydroxysultaine, Glycerin, Fragrance, Tetrasodium EDTA, Citric Acid, Methylchloroisothiazolinone, Methylisosthiazolinone, FD&C Blue #1.

  • QUESTIONS

    Questions? 888-GO BETCO (888-462-3826)

  • Amazon Commerical Antibacterial Foam

    Purpose

    Antibacterial

  • Amazon Commerical Antibacterial Foam

    KEEP OUT OF REACH OF CHILDREN

  • Amazon Commerical Antibacterial Foam

    Updated label RTK ingredient

  • INGREDIENTS AND APPEARANCE
    AMAZON COMMERCIAL ANTIBACTERIAL FOAMING SKIN CLEANSER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-759
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    COCAMINE OXIDE (UNII: QWA2IZI6FI)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PEG-4 RAPESEEDAMIDE (UNII: 89575CN928)  
    COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ALCOHOL (UNII: 3K9958V90M)  
    BENZYL ACETATE (UNII: 0ECG3V79ZJ)  
    SODIUM GLYCOLATE (UNII: B75E535IMI)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    TRISODIUM NITRILOTRIACETATE (UNII: E3C8R2M0XD)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    2,4-DIMETHYL-3-CYCLOHEXENE CARBOXALDEHYDE (UNII: 452GFV2AFS)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    CAPRYLYL/CAPRYL OLIGOGLUCOSIDE (UNII: E00JL9G9K0)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    GERANIOL (UNII: L837108USY)  
    LIME OIL (UNII: UZH29XGA8G)  
    2-METHYLUNDECANAL (UNII: S94QNS2VY5)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    ALLYL CYCLOHEXANEPROPIONATE (UNII: H4W9H3L241)  
    GERANYL ACETATE (UNII: 3W81YG7P9R)  
    CITRONELLYL ACETATE (UNII: IZ420RT3OY)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CITRAL (UNII: T7EU0O9VPP)  
    FORMALDEHYDE (UNII: 1HG84L3525)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-759-043780 mL in 1 JUG; Type 0: Not a Combination Product11/12/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/12/2012
    Labeler - Amazon (128990418)
    Registrant - Betco Corporation, Ltd (024492831)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd024492831manufacture(72288-759) , label(72288-759)
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