Label: ANTI-BACTERIAL HAND GEL- 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 September 25, 2015

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  • ACTIVE INGREDIENT

    Active Ingredient:
    Ethyl Alcohol 62%

  • PURPOSE

    Purpose Antiseptic

  • WARNINGS

    Warnings:For external use only.

    Flammable. Keep away from fire or flame.

  • STOP USE

    Stop use and ask for a doctor if irritation or rash appears and lasts.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a doctor right away.

  • DOSAGE & ADMINISTRATION

    Directions:
    Pump as needed into your palms to cover hands. Rub hands together briskly until dry. Children under 6 years old should be supervised when using this product.

  • INACTIVE INGREDIENT

    Inactive Ingredients: Water, Aloe Barbadensis Leaf Juice, Glycerin, Propylene Glycol, Fragrance, Carbomer, Aminomethyl Propanol, Lactose, Microcrystalline Cellulose, Sucrose, Zea Mays (corn) Starch, Ultramarine Blue CI 77007, Tocopheryl Acetate, Hydroxpropyl Methyl Cellulose, FD&C Blue No.1, FD&C Yellow No.5, FD&C Red No.33, FD&C Red No.4.

  • STORAGE AND HANDLING

    Other Information: Store below 118 F.

  • INDICATIONS & USAGE

    UseTo help reduce bacteria on the skin

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    ANTI-BACTERIAL HAND GEL 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69358-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    ULTRAMARINE BLUE (UNII: I39WR998BI)  
    AMINOMETHYL PROPANEDIOL (UNII: CZ7BU4QZJZ)  
    LACTOSE (UNII: J2B2A4N98G)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    SUCROSE (UNII: C151H8M554)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69358-0008-129 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product09/25/2015
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/25/2015
    Labeler - UniGroup Wholesale Inc. (079591424)
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