Label: ADVANCED HAND SANITIZER SINGLES- ethyl alcohol 70% liquid

  • Category: HUMAN OTC DRUG LABEL

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 September 25, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the 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

    • Open the single pouch and put the entire amount of hand sanitizer on your palm.
    • Rub hands briskly until dry for about 15 seconds.
    • Children under 6 years of age should be supervised when using this product.
  • Other Information

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

    Water, Glycerin, Carbomer, Tromethamine, Aloe Barbadensis Leaf Extract

  • Principal Display Panel

    pouch

  • INGREDIENTS AND APPEARANCE
    ADVANCED HAND SANITIZER SINGLES 
    ethyl alcohol 70% liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67510-2134
    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 980 (UNII: 4Q93RCW27E)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROMETHAMINE (UNII: 023C2WHX2V)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67510-2134-46 mL in 1 POUCH; Type 0: Not a Combination Product09/23/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/23/2020
    Labeler - Kareway Product, Inc. (121840057)
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