Label: ANTI-BACTERIAL HAND SANITIZER- ethyl alcohol gel

  • 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 18, 2017

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  • ACTIVE INGREDIENT

    Active Ingredient:
    Ethyl Alcohol 63%

  • PURPOSE

    Purpose:
    Antiseptic

  • WARNINGS

    Warnings:
    For external use only. Flammable, keep away from fire, flame and direct sunlight.

  • STOP USE

    Stop using this product and consult a doctor If irritation or redness develops.Stop using this product and consult a doctor If irritation or redness develops.

  • DOSAGE & ADMINISTRATION

    Directions

    • Rub dime sized amount between hands until dry.
    • For use by children under 6 years, adult supervision is required.
  • INACTIVE INGREDIENT

    Water, Propylene Glycol, Carbomer, Aminomethyl Propanol, Glycerin, Denotonium Benzoate

  • INDICATIONS & USAGE

    Uses To help reduce bacteria on hands.

  • WHEN USING


    When using this product Avoid contact with eyes and lips. If contact occurs, rinse with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center immediately.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69583-003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL63 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69583-003-0029 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product11/12/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/12/2015
    Labeler - Fun Zone, Inc. (803572929)
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