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 13, 2011

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  • ACTIVE INGREDIENT

    ETHYL ALCOHOL 62%

  • PURPOSE

    ANTIMICROBIAL

  • USES

    HAND SANITIZER TO HELP REDUCE BACTERIA ON THE SKIN.

  • WARNINGS

    FOR EXTERNAL USE ONLY. KEEP AWAY FROM FIRE.

    WHEN USING THIS PRODUCT

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

    STOP USING THIS PRODUCT AND ASK A DOCTOR IF

    IRRITATION OR RASH DEVELOPS AND LASTS.

    KEEP OUT OF REACH OF CHILDREN

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

  • DIRECTIONS

    PLACE ENOUGH PRODUCT IN YOUR PALM TO THOROUGHLY COVER YOUR HANDS.  RUB HANDS TOGETHER BRISKLY UNTIL DRY.  CHILDREN UNDER 6 YEARS OF AGE SHOULD BE SUPERVISED WHEN USING THIS PRODUCT.

  • OTHER INFORMATION

    STORE AT TEMPERATURE BELOW 1100C (430C)

  • INACTIVE INGREDIENTS

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

  • 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:55316-225
    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)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CARBOMER 934 (UNII: Z135WT9208)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55316-225-08236 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E10/13/2011
    Labeler - DZA BRANDS (090322194)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture
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