Label: HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP- chloroxylenol liquid

  • 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 November 22, 2013

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  • Active ingredient

    Chloroxylenol 0.3%

  • Purpose

    Antimicrobial

  • Use

    Handwash to help decrease bacteria on the skin before and after contact with a person under medical care or treatment

    Recommended for repeated use

  • 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, Aloe Barbadensis Leaf Juice, Cocamide MEA, Coco-Betaine, Hydrolyzed Vegetable Protein, Propylene Glycol, Retinyl Palmitate, Tetrasodium EDTA, Tocopheryl Acetate, Zea Mays (Corn) Oil, Hydroxypropyl Methylcellulose, Fragrance (Parfum)

  • PRINCIPAL DISPLAY PANEL

    For general hand washing and germ killing

    Label

  • 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.

  • INGREDIENTS AND APPEARANCE
    HIGHMARK PROFESSIONAL GOLD AND CLEAN ANTIMICROBIAL LTN SP 
    chloroxylenol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61139-421
    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)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    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)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61139-421-80800 mL in 1 BAG
    2NDC:61139-421-891200 mL in 1 BOTTLE
    3NDC:61139-421-901250 mL in 1 BOTTLE
    4NDC:61139-421-101000 mL in 1 BOTTLE
    5NDC:61139-421-202000 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E11/22/2013
    Labeler - Office Max, Inc. (009073099)
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