PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]

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PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX (CHLOROXYLENOL) LIQUID [GOJO INDUSTRIES, INC.]
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NDC 21749-750-04, 21749-750-08, 21749-750-10, 21749-750-12, 21749-750-16, 21749-750-20, 21749-750-37, 21749-750-50, 21749-750-80
Set ID d9dfd7fe-6a24-4815-a9c8-4c45b4bf65b3
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 0.3%

  • Purpose

    Antimicrobial

  • Use

    • 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), Coconut Acid, Oleic Acid, Sodium Sulfate, Ethanolamine, Cocamide MEA, Coco-Betaine, Propylene Glycol, Retinyl Palmitate, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Hydroxypropyl Methylcellulose, Fragrance (Parfum)

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    PROVON ANTIMICROBIAL LTN SP WITH 0.3% PCMX 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21749-750
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Chloroxylenol (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) Chloroxylenol0.003 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Coconut Acid (UNII: 40U37V505D)  
    Oleic Acid (UNII: 2UMI9U37CP)  
    Sodium Sulfate (UNII: 0YPR65R21J)  
    MONOETHANOLAMINE (UNII: 5KV86114PT)  
    COCO MONOETHANOLAMIDE (UNII: C80684146D)  
    Coco-Betaine (UNII: 03DH2IZ3FY)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    VITAMIN A PALMITATE (UNII: 1D1K0N0VVC)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    CORN OIL (UNII: 8470G57WFM)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21749-750-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2013
    2NDC:21749-750-08236 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2013
    3NDC:21749-750-12355 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2013
    4NDC:21749-750-16473 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2013
    5NDC:21749-750-50500 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2013
    6NDC:21749-750-80800 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2013
    7NDC:21749-750-101000 mL in 1 BAG; Type 0: Not a Combination Product08/31/2013
    8NDC:21749-750-202000 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2013
    9NDC:21749-750-373784 mL in 1 BOTTLE; Type 0: Not a Combination Product08/31/2013
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E08/31/2013
    Labeler - GOJO Industries, Inc. (004162038)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.036424534manufacture(21749-750)
    Establishment
    NameAddressID/FEIBusiness Operations
    GOJO Industries, Inc.088312414label(21749-750) , pack(21749-750)
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