Label: PURELL FOODSERVICE ADVANCED HAND SANITIZER FOAM- alcohol liquid

  • NDC Code(s): 21749-812-53, 21749-812-89
  • 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%

  • Purpose

    Antimicrobial

  • Use

    Hand sanitizer to help reduce bacteria on the skin that could cause disease

  • 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.

  • Other information

    Store below 110oF (43oC)

    May discolor certain fabrics or surfaces

  • Inactive ingredients

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

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    PURELL FOODSERVICE ADVANCED HAND SANITIZER FOAM 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-812
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.70 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Isopropyl Alcohol (UNII: ND2M416302)  
    Glycerin (UNII: PDC6A3C0OX)  
    Isopropyl Myristate (UNII: 0RE8K4LNJS)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Caprylyl Glycol (UNII: 00YIU5438U)  
    PEG-12 DIMETHICONE (300 CST) (UNII: ZEL54N6W95)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-812-53535 mL in 1 PACKAGE; Type 0: Not a Combination Product09/05/2017
    2NDC:21749-812-891200 mL in 1 PACKAGE; Type 0: Not a Combination Product09/05/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/05/2017
    Labeler - GOJO Industries, Inc. (004162038)
    Registrant - GOJO Industries, Inc. (004162038)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.036424534manufacture(21749-812)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.088312414manufacture(21749-812) , label(21749-812) , pack(21749-812)
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