PURELL HEALTHCARE HEALTHY SP 0.5PCT PCMX ANTIMICROBIAL FOAM (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]

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  • PURELL HEALTHCARE HEALTHY SP 0.5PCT PCMX ANTIMICROBIAL FOAM (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]

PURELL HEALTHCARE HEALTHY SP 0.5PCT PCMX ANTIMICROBIAL FOAM (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]
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NDC 21749-522-53, 21749-522-89, 21749-522-90
Set ID bd4682ce-6cc3-4e4c-9e64-b8ffb4ec7835
Category HUMAN OTC DRUG LABEL
Packager GOJO Industries, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • Active ingredient

    Chloroxylenol 0.5%

  • Purpose

    Antimicrobial

  • Use

    • Handwash to help reduce bacteria on the skin
    • Recommended for repeated use
  • Warnings

    For external use only

    Wwhen 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), Alcohol, Lauric Acid, Ethanolamine, Dipropylene Glycol, Lactic Acid, Poloxamer 124, Isopropyl Alcohol, Sodium Metabisulfite, Sodium Sulfite, Tetrasodium EDTA, Sodium Sulfate, Fragrance (Parfum), Methylparaben, Propylparaben

  • PRINCIPAL DISPLAY PANEL

    Product Label

  • INGREDIENTS AND APPEARANCE
    PURELL HEALTHCARE HEALTHY SP 0.5PCT PCMX ANTIMICROBIAL FOAM 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-522
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.005 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    ALCOHOL (UNII: 3K9958V90M)  
    LAURIC ACID (UNII: 1160N9NU9U)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    DIPROPYLENE GLYCOL (UNII: E107L85C40)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    POLOXAMER 124 (UNII: 1S66E28KXA)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    SODIUM METABISULFITE (UNII: 4VON5FNS3C)  
    SODIUM SULFITE (UNII: VTK01UQK3G)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-522-53535 mL in 1 PACKAGE; Type 0: Not a Combination Product07/14/2017
    2NDC:21749-522-891200 mL in 1 PACKAGE; Type 0: Not a Combination Product07/14/2017
    3NDC:21749-522-901250 mL in 1 PACKAGE; Type 0: Not a Combination Product07/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E07/14/2017
    Labeler - GOJO Industries, Inc. (004162038)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.036424534manufacture(21749-522)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.088312414label(21749-522) , pack(21749-522)
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