Label: INSTANT HAND SANITIZER WITH SHEA BUTTER- 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 January 31, 2011

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62%

  • PURPOSE

    ANTISEPTIC

  • USES

    TO DECREASE BACTERIA ON THE SKIN THAT COULD CAUSE DISEASE. RECOMMENDED FOR REPEATED USE.

  • WARNINGS

    FOR EXTERNAL USE ONLY-HANDS.

    FLAMMABLE.  KEEP AWAY FROM HEAT AND FLAME.

    WHEN USING THIS PRODUCT

    KEEP OUT OF EYES.  IN CASE OF CONTACT WITH EYES, FLUSH THOROUGHLY WITH WATER. AVOID CONTACT WITH BROKEN SKIN.

    STOP USE AND ASK A DOCTOR

    IF SKIN IRRITATION DEVELOPS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    WET HANDS THOROUGHLY WITH PRODUCT AND ALLOW TO DRY WITHOUT WIPING.  FOR CHILDREN UNDER 6, USE ONLY UNDER ADULT SUPERVISION.  NOT RECOMMENDED FOR INFANTS.

  • OTHER INFORMATION

    DO NOT STORE ABOVE 105 DEGREES FAHRENHEIT.  MAY DISCOLOR SOME FABRICS, HARMFUL TO WOOD FINISHES AND PLASTICS.

  • INACTIVE INGREDIENTS

    WATER, PROPYLENE GLYCOL, GLYCERIN, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE, AMINOMETHYL PROPANOL, BUTYROSPERMUM PARKII (SHEA BUTTER), MANNITOL, CELLULOSE, HYDROXYPROPYL METHYLCELLULOSE, CARBOMER, FRAGRANCE, IRON OXIDES (CI 77491), IRON OXIDES (CI 77492).

  • PRINCIPAL DISPLAY PANEL

    IMAGE OF INSTANT HAND SANITIZER

  • INGREDIENTS AND APPEARANCE
    INSTANT HAND SANITIZER  WITH SHEA BUTTER
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-224
    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)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    SHEA BUTTER (UNII: K49155WL9Y)  
    MANNITOL (UNII: 3OWL53L36A)  
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    CARBOMER 934 (UNII: Z135WT9208)  
    FERRIC OXIDE RED (UNII: 1K09F3G675)  
    FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-224-0259 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/31/2011
    Labeler - CVS PHARMACY (062312574)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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