Label: PURELL HEALTHCARE HEALTHY SP 0.5 BAK ANTIMICROBIAL FOAM- benzalkonium chloride liquid

  • NDC Code(s): 21749-687-40, 21749-687-42
  • 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 June 15, 2019

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  • Active ingredient

    Benzalkonium Chloride 0.5%

  • Purpose

    Antimicrobial

  • Uses

    • Handwash to help decrease bacteria on the skin

    • Recommended for repeated use

  • 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

    • Apply a small amount of product and work into a lather

    • Rinse well and dry hands completely

  • Inactive Ingredients

    Water (Aqua), Propanediol, Glycerin, Cocamidopropyl Betaine, PEG-80 Sorbitan Laurate, Citric Acid, Ethylhexylglycerin, Lauramine Oxide, Polyquaternium-10, Trisodium Ethylenediamine Disuccinate, Fragrance (Parfum), Phenoxyethanol

  • PRINCIPAL DISPLAY PANEL

    Product LabelProduct Label

  • INGREDIENTS AND APPEARANCE
    PURELL HEALTHCARE HEALTHY SP 0.5 BAK ANTIMICROBIAL FOAM 
    benzalkonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-687
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzalkonium Chloride (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) Benzalkonium Chloride0.005 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    PROPANEDIOL (UNII: 5965N8W85T)  
    Glycerin (UNII: PDC6A3C0OX)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    PEG-80 Sorbitan Laurate (UNII: 239B50Y732)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Ethylhexylglycerin (UNII: 147D247K3P)  
    Lauramine Oxide (UNII: 4F6FC4MI8W)  
    POLYQUATERNIUM-10 (10000 MPA.S AT 2%) (UNII: PI1STR9QYH)  
    TRISODIUM ETHYLENEDIAMINE DISUCCINATE (UNII: YA22H34H9Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-687-401200 mL in 1 PACKAGE; Type 0: Not a Combination Product06/15/2019
    2NDC:21749-687-421250 mL in 1 PACKAGE; Type 0: Not a Combination Product06/15/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E06/15/2019
    Labeler - GOJO Industries, Inc. (004162038)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.036424534manufacture(21749-687)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.088312414label(21749-687) , pack(21749-687)
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