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

    ANTIMICROBIAL

  • USES

    TO HELP REDUCE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY-HANDS.

    FLAMMABLE. KEEP AWAY FROM FIRE OR FLAME.

    WHEN USING THIS PRODUCT

    AVOID CONTACT WITH EYES. IF CONTACT OCCURS, RINSE WITH WATER.

    STOP USING AND ASK A DOCTOR

    IF IRRITATION OR RASH APPEARS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

    IN CASE OF ACCIDENTAL INGESTION, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY.

  • DIRECTIONS

    APPLY A SMALL AMOUNT IN YOUR PALM AND RUB HANDS TOGETHER BRISKLY UNTIL DRY.  CHILDREN UNDER 6 SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

  • OTHER INFORMATION

    STORE AT A TEMPERATURE BELOW 110 DEGREES FAHRENHEIT (43 DEGREES CELCIUS).
  • 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 cvs51

  • 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:59779-224-0115 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