Label: FOAMING HAND SANITIZER- benzethonium chloride liquid

  • 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 February 9, 2010

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  • Drug Facts Box OTC-Active Ingredient Section

    benzethonium chloride USP 0.2%

  • Drug Facts Box OTC-Indications & Usage Section

    For hand-washing to decrease bacteria on the skin, only when water is not available

  • Drug Facts Box OTC-Warnings Section

    For external use only

  • Drug Facts Box OTC-Purpose Section

    Antiseptic

  • Drug Facts Box-OTC When Using Section

    do not get into eyes

    if contact occurs, rinse eyes thoroughly with water

  • Drug Facts Box-OTC Stop Use Section

    irritation and redness develop

  • Drug Facts Box-OTC Keep Out Of Reach Of Children Section

    If swallowed, get medical help or contact a Poison Control Center right away

  • Drug Facts Box-OTC Dosage & Administration Section

    press pump twice to deliver two squirts (about a quarter size) of foaming product onto the palm of your hand

    rub hands together until dry

    wash hands with soap and water at earliest opportunity

  • Drug Facts Box-OTC Inactive Ingredient Section

    water, glycerine, dimethicone, DMDM hydantoin, iodopropynl butylcarbamate, fragrance

  • Foaming Hand Sanitizer 6575 1 gallon

    657541S9830.jpg  Foaming Hand Sanitizer 1 gallonimage of bottle label

  • INGREDIENTS AND APPEARANCE
    FOAMING HAND SANITIZER 
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50466-575
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZETHONIUM CHLORIDE (UNII: PH41D05744) (BENZETHONIUM - UNII:1VU15B70BP) BENZETHONIUM CHLORIDE2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    1,3-DIMETHYLOL-5,5-DIMETHYL-HYDANTOIN (UNII: BYR0546TOW)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50466-575-101000 mL in 1 CARTRIDGE
    2NDC:50466-575-121000 mL in 1 BAG
    3NDC:50466-575-13800 mL in 1 BAG
    4NDC:50466-575-143785 mL in 1 BOTTLE, PLASTIC
    5NDC:50466-575-15946 mL in 1 BOTTLE, PLASTIC
    6NDC:50466-575-16236 mL in 1 BOTTLE, PLASTIC
    7NDC:50466-575-17532 mL in 1 BOTTLE, PLASTIC
    8NDC:50466-575-1850 mL in 1 BOTTLE, PLASTIC
    9NDC:50466-575-24115 mL in 1 BOTTLE, PLASTIC
    10NDC:50466-575-55208200 mL in 1 DRUM
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33307/31/2009
    Labeler - Interstate Solutions, Inc. (098249477)
    Registrant - ABC Compounding Co., Inc. (003284353)
    Establishment
    NameAddressID/FEIBusiness Operations
    ABC Compounding Co., Inc.003284353manufacture
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