Label: ADVANCED 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 10, 2019

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  • Active ingredient

    Ethyl Alcohol 70%

    Purpose

    Antiseptic

  • Uses

    to help reduce bacteria on the skin.

  • Warnings

    For external use only

    • flammable
    • keep away from source of heat or fire

    When using this product

    avoid contact with eyes. If contact occurs, rinse thoroughly with water.

    Stop use and ask a 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 immediately.

  • Directions

    • put enough product in your palm to cover hands and rub hands together until dry.
    • children under 6 years should be supervised when using this product.
  • Other information

    • store at a temperature below 110°F (43°C).
    • may discolor certain fabrics or surfaces.
  • Inactive ingredients

    Water (Aqua), Fragrance (Parfum), Carbomer, Glycerin, Isopropyl Myristate, Isopropyl Alcohol, Aminomethyl Propanol, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate, Blue 1 (CI 42090), Yellow 5 (CI 19140).

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-070
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL700 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER 934 (UNII: Z135WT9208)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-070-15443 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/09/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/09/2019
    Labeler - CVS Pharmacy (062312574)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(59779-070)
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