Label: ADVANCED HAND SANITIZER- ethyl alcohol 70% liquid

  • NDC Code(s): 67510-0132-1, 67510-0132-8
  • Packager: Kareway Product, Inc.
  • 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 30, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antiseptic

  • Use

    Hand sanitizer to help reduce bacteria on skin

  • Warnings

    ​Flammable, Keep away from fire or flame.

    For external use only.

    When using this product

    do not use in or near the eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    irritation or rash appears and lasts

    Keep out of reach of children

    If swallowed, get medical help or contact or contact a Poison Control Center right away

  • Directions

    • Put enough product in your palm to cover hands and rub hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product.
  • Other Information

    • Store below 110ºF (43ºC)
  • Inactive Ingredients

    Water (Aqua), Aminomethyl Propano, Carbomer, Citrus Aurantium Dulcis (Orange) Fruit Extract, Fragrance, Propylene Glycol, 1,2-Hexanediol, Denatonium Benzoate

  • Principal Display Panel

    label

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER 
    ethyl alcohol 70% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-0132
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: HHT01ZNK31)  
    ORANGE OIL (UNII: AKN3KSD11B)  
    1,2-HEXANEDIOL (UNII: TR046Y3K1G)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DENATONIUM BENZOATE (UNII: 4YK5Z54AT2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-0132-8250 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    2NDC:67510-0132-1500 mL in 1 BOTTLE; Type 0: Not a Combination Product04/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/30/2020
    Labeler - Kareway Product, Inc. (121840057)