Label: PURELL HAND SANITIZING WIPES- benzalkonium chloride cloth

  • NDC Code(s): 21749-368-10, 21749-368-12, 21749-368-15, 21749-368-17, view more
    21749-368-27, 21749-368-35
  • 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 February 25, 2022

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  • Active ingredient

    Benzalkonium Chloride 0.13%

  • Purpose

    Antimicrobial

  • Uses

    • Hand sanitizer to help reduce bacteria on the skin
  • Warnings

    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

    • Wet hands thoroughly with product and allow to dry
    • Children under 6 years of age should be supervised when using PURELL
  • Inactive ingredients

    Water (Aqua), Decyl Glucoside, Glycerin, Fragrance(Parfum), Phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    Product LabelProduct LabelProduct LabelProduct Label

  • INGREDIENTS AND APPEARANCE
    PURELL HAND SANITIZING WIPES 
    benzalkonium chloride cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-368
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.13 mg  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-368-3535 in 1 PACKAGE03/14/201207/01/2022
    1150 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:21749-368-10100 in 1 PACKAGE03/14/2012
    2245 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:21749-368-27270 in 1 PACKAGE03/14/2012
    3667 mL in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:21749-368-121200 in 1 PACKAGE03/14/2012
    42567 mL in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:21749-368-151500 in 1 PACKAGE03/14/2012
    52674 mL in 1 PACKAGE; Type 0: Not a Combination Product
    6NDC:21749-368-171700 in 1 PACKAGE05/01/2018
    62273 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E03/14/2012
    Labeler - GOJO Industries, Inc. (004162038)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.036424534MANUFACTURE(21749-368)
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