Label: 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 April 8, 2013

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  • ACTIVE INGREDIENT

    ACTIVE INGREDIENT
    ETHYL ALCOHOL 62% V/V

  • PURPOSE

    PURPOSE:

    ANTISEPTIC

  • INDICATIONS & USAGE

    USES

    HAND SANITIZER TO HELP REDUCE BACTERIA ON SKIN THAT COULD CAUSE DISEASE

  • WARNINGS

    Warnings
    For external use only

    Flammable, keep away from fire or flame

  • OTHER SAFETY INFORMATION

    Other information Do not store above 110F (43C).
    Store in an area inaccessible to children.

  • WHEN USING

    When using this product
    ■ Avoid contact with eyes. If in eyes, flush with water.

    ■ Do not ingest.

    ■ Discontinue use and contact a doctor if irritation and redness develop and conditions persist for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center immediately. In case of transportaton or first aid emergency contact CHEMTEL 1-800-255-3924.

  • DOSAGE & ADMINISTRATION

    Directions

    Place small amount in your palm and rub hands together until dry. Children under 6 years of age should be supervised when using this product.

  • INACTIVE INGREDIENT

    Inactive ingredients

    Aloe Vera Extract, Carbomer, Fragrance, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Propylene Glycol, Tocopheryl Acetate,
    Vitamin E, Water.

  • PRINCIPAL DISPLAY PANEL

    HDX_Sanitizer_ART_2oz_Blister-FR 2012-05-03

    HDX_Sanitizer_ART_2oz_LBL_BK 2012-05-03

    HDX_Sanitizer_ART_2oz_LBL_FR 2012-05-03

    HDX_Sanitizer_ART_8oz_LBL_2013-04-08

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42584-1001
    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
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42584-1001-8236 mL in 1 BOTTLE, PUMP
    2NDC:42584-1001-21 in 1 BLISTER PACK
    2NDC:42584-1001-153 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E02/14/2012
    Labeler - HOME DEPOT U.S.A. INC. (783266950)
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