Label: GIANT EAGLE ALOE HAND SANITIZER- ethyl alcohol liquid

  • 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 June 11, 2018

If you are a consumer or patient please visit this version.

  • 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. 1-800-222-1222.

  • Directions

    • Put enough hand sanitizer 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), Isopropyl Alcohol, Aloe Barbadensis Leaf Juice, Propylene Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate, Carbomer, Aminomethyl Propanol, Fragrance (Parfum), Ethylhexylglycerin, Yellow 5 (CI 19140), Blue 1 (CI 42090).

  • Labe copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    GIANT EAGLE ALOE HAND SANITIZER 
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63148-013
    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)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    CARBOMER 934 (UNII: Z135WT9208)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63148-013-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2018
    2NDC:63148-013-0259 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/08/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/08/2018
    Labeler - Apollo Health and Beauty Care Inc. (201901209)
    Registrant - Apollo Health and Beauty Care Inc. (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apollo Health and Beauty Care Inc.201901209manufacture(63148-013)