Label: PURELL ADVANCED E3 RATED INSTANT HAND SANITIZER FOAM- alcohol liquid

  • NDC Code(s): 21749-802-51, 21749-802-53, 21749-802-89, 21749-802-97
  • Packager: GOJO Industries, 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 December 27, 2019

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  • Active ingredient

    Ethyl alcohol 70% v/v

  • Purpose

    Antimicrobial

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin that cause disease
    • Recommended for repeated use
  • 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
    • Run hands together briskly until dry
    • Children under 6 years of age should be supervised when using this product.
  • Inactive ingredients

    Water (Aqua), Isopropyl Alcohol, PEG-12 Dimethicone, Caprylyl Glycol, Glycerin, Isopropyl Myristate, Tocopheryl Acetate

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    PURELL ADVANCED E3 RATED INSTANT HAND SANITIZER FOAM 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-802
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.7 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-802-51550 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2012
    2NDC:21749-802-53535 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2012
    3NDC:21749-802-97700 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2012
    4NDC:21749-802-891200 mL in 1 BOTTLE; Type 0: Not a Combination Product06/01/2012
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/01/2012
    Labeler - GOJO Industries, Inc. (004162038)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.036424534MANUFACTURE(21749-802)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.088312414manufacture(21749-802) , label(21749-802) , pack(21749-802)
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