Label: AMAZON COMMERCIAL ALCOHOL FREE FOAM HAND SANITIZER- 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

    ​Active Ingredient

    Benzalkonium Chloride 0.13%

  • INDICATIONS & USAGE

    Uses

    • Use in a variety of public facilities.
    • Use this product when soap and water are not available.
  • WARNINGS

    Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Children under the age of 6 should be supervised by an adult when using this product.
    • Discontinue use is irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.
  • DOSAGE & ADMINISTRATION

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense product onto dry hands. Rub hands together until hands are dry.
    • Use as needed between hand washes to reduce bacteria on the skin.
  • INACTIVE INGREDIENT

    Inactive Ingredients

    Deionized ​Water, Sodium PCA, PEG/PPG-8/3 Laurate, Dimethicone, DMDM Hydantoin, PEG-3 Cocamide, Fragrance, Iodoproynyl Btylcarbamate, D&C Green #5.

  • QUESTIONS

    Questions or Comments?Phone: (800) 777-9343

    MDS information:​(800) 891-4965

  • PURPOSE

    Purpose

    Antiseptic

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN

  • Amazon Commercial Alcohol Free Foam Hand Sanitizer

    Label change RTK ingredients

  • INGREDIENTS AND APPEARANCE
    AMAZON COMMERCIAL ALCOHOL FREE FOAM HAND SANITIZER 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72288-752
    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
    GERANIOL (UNII: L837108USY)  
    SODIUM PIDOLATE (UNII: 1V74VH163T)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    PEG/PPG-15/15 ALLYL ETHER ACETATE (UNII: 8RP39FN7AJ)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    N-ALKYL DIMETHYL BENZYL AMMONIUM CHLORIDE (C12-C18) (UNII: 9U1Q4T4ZYS)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    .BETA.-CITRONELLOL, (+/-)- (UNII: 565OK72VNF)  
    DIOXANE (UNII: J8A3S10O7S)  
    METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
    METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
    CYCLOMETHICONE 4 (UNII: CZ227117JE)  
    HEXYL SALICYLATE (UNII: 8F78EY72YL)  
    ALCOHOL (UNII: 3K9958V90M)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ACETALDEHYDE (UNII: GO1N1ZPR3B)  
    LIME OIL (UNII: UZH29XGA8G)  
    LEMON OIL (UNII: I9GRO824LL)  
    MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
    HEXAMETHYLINDANOPYRAN (UNII: 14170060AT)  
    MYRCENE (UNII: 3M39CZS25B)  
    DIHYDROMYRCENOL (UNII: 46L1B02ND9)  
    METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)  
    LINALOOL, (+/-)- (UNII: D81QY6I88E)  
    BUTYLPHENYL METHYLPROPIONAL (UNII: T7540GJV69)  
    WATER (UNII: 059QF0KO0R)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72288-752-043870 mL in 1 JUG; Type 0: Not a Combination Product10/01/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2015
    Labeler - Amazon.com Services (128990418)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.005050158manufacture(72288-752) , pack(72288-752) , label(72288-752)
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