Label: PURELL ADVANCED HAND SANITIZER PRIME DEFENSE- alcohol gel

  • NDC Code(s): 21749-905-04, 21749-905-12
  • Packager: GOJO Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2020

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  • Active ingredient

    Ethyl alcohol 85% 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 a Poison Control Center right away.

  • Directions

    · Place enough product in your palm to thoroughly cover your hands

    · Rub hands together briskly until dry

    · Children under 6 years of age should be supervised when using this product.

  • Inactive ingredients

    Water (Aqua), Isopropyl Alcohol, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Aminomethyl Propanol

  • PRINCIPAL DISPLAY PANEL

    Product Front Label
    Product Drug Facts Label
    Product Back Label
  • INGREDIENTS AND APPEARANCE
    PURELL ADVANCED HAND SANITIZER PRIME DEFENSE 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-905
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL85 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    ACRYLATES/C10-30 ALKYL ACRYLATE CROSSPOLYMER (60000 MPA.S) (UNII: 8Z5ZAL5H3V)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-905-04118 mL in 1 PACKAGE; Type 0: Not a Combination Product11/17/2020
    2NDC:21749-905-12354 mL in 1 PACKAGE; Type 0: Not a Combination Product12/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM505G(a)(3)11/17/2020
    Labeler - GOJO Industries, Inc. (004162038)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.036424534manufacture(21749-905) , pack(21749-905) , label(21749-905)
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