Label: HAND SANITIZER WITH MOISTURIZERS AND VITAMIN E- 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 October 12, 2011

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 65 PERCENT

  • PURPOSE

    ANTISEPTIC

  • USES

    TO HELP REDUCE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY. FLAMMABLE, KEEP AWAY FROM FIRE OR FLAME.

    WHEN USING THIS PRODUCT

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

    STOP USING THIS PRODUCT AND ASK DOCTOR IF

    IRRITATION OR REDNESS DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

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

  • 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

    DO NOT STORE ABOVE 1100F (430C).

  • QUESTIONS OR COMMENTS

    1-866-322-2439

  • INACTIVE INGREDIENTS

    WATER, ISOPROPYL ALCOHOL, GLYCERIN, CARBOMER, AMINOMETHYL PROPANOL, FRAGRANCE, PROPYLENE GLYCOL, ISOPROPYL MYRISTATE, TOCOPHERYL ACETATE.

  • Front and back labels

    image of label
  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  WITH MOISTURIZERS AND VITAMIN E
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-267
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 934 (UNII: Z135WT9208)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55316-267-0259 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/12/2011
    Labeler - DZA BRANDS (090322194)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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