Label: HAND SANITIZER- alcohol gel

  • NDC Code(s): 80228-2001-1
  • Packager: Universal Synergetics, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 6, 2023

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  • ACTIVE INGREDIENT

    Ethyl Alcohol 70%

  • PURPOSE

    Antimicrobial

  • USES

    Hand sanitizer to help reduce bacteria on skin.

  • WARNINGS

    Flammable -For external use only - Avoid eye contact. If in the eyes flush with water.

    Stop use and ask a doctor if irritation or rash develops and lasts

    - Keep out of reach of children - If swallowed get medical help or call a Poison Control Center right away.

  • DIRECTIONS

    Put enough in palm to cover hands - Rub hands briskly until dry. - Children under 6 years of age should be supervised when using this product.

  • INACTIVE INGREDIENTS

    Water(Aqua) Alicyle Acrylate, Crosspolymer, Aminomethyl Propanol, Caprylyl Glycol, Glycerin, Isopropyl Alcohol, Isopropyl Myristate, Fragrance, Tocopherol Acetate

  • QUESTIONS

    Questions: 833-523-1109

  • Other information:

    Store below 110° F (43°C) May discolor certain fabrics and surfaces

  • Principal Display Panel

    Principal Display Panel - 1.2 mL Pouch Label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80228-2001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.84 mL  in 1.2 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) (UNII: 59TL3WG5CO)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:80228-2001-11.2 mL in 1 POUCH; Type 0: Not a Combination Product04/13/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00303/01/2021
    Labeler - Universal Synergetics, Inc (069033371)
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