Label: GOLDEN MEDICATED- chloroxylenol solution 

  • NDC Code(s): 50865-060-09, 50865-060-27
  • Packager: Kutol Products Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/14

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  • ACTIVE INGREDIENT

    Chloroxylenol 0.3% w/w.......Antibacterial Handwashing

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  • INACTIVE INGREDIENT

    Water, Tall Oil Acid, Potassium Hydroxide, Sodium Lauryl Sulfate, Coconut Acid, Cocamide DIPA, Phenoxyethanol, Tetrasodium EDTA, Sodium Sulfate, Sodium Laureth Sulfate, Aloe Barbadensis Leaf Juice, Tocopheryl Acetate (Vitamin E), Iodopropynyl Butylcarbamate, Fragrance, Red 33, Yellow 5.

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  • PURPOSE

    Handwash to help decrease bacteria on the skin.

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  • WARNINGS

    For external use only.

    Do not use in the eyes. In case of contact, immediately flush 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.

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  • DOSAGE & ADMINISTRATION

    • Apply a small amount, covering hands with product for 30 seconds. Add water, lather and rinse.
    • Children under 6 years of age should be supervised when using this product.
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  • INDICATIONS & USAGE

    Handwash to help decrease bacteria on the skin.

    Do not use in the eyes. In case of contact, immediately flush 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.

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  • PRINCIPAL DISPLAY PANEL

    50865-060-09.jpg  50865-060-09.jpg

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  • PRINCIPAL DISPLAY PANEL

    50865-060-27.jpg  50865-060-27.jpg

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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  • INGREDIENTS AND APPEARANCE
    GOLDEN MEDICATED 
    medicated lotion soap solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50865-060
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLOROXYLENOL (CHLOROXYLENOL) CHLOROXYLENOL 0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    POTASSIUM HYDROXIDE  
    COCONUT ACID  
    SODIUM LAURYL SULFATE  
    PHENOXYETHANOL  
    SODIUM LAURETH SULFATE  
    IODOPROPYNYL BUTYLCARBAMATE  
    SODIUM SULFATE  
    D&C RED NO. 33  
    FD&C YELLOW NO. 5  
    EDETATE SODIUM  
    TALL OIL ACID  
    ALOE VERA LEAF  
    .ALPHA.-TOCOPHEROL ACETATE  
    COCO DIISOPROPANOLAMIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50865-060-09 3785 mL in 1 BOTTLE, PLASTIC
    2 NDC:50865-060-27 1000 mL in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 03/11/2014
    Labeler - Kutol Products Company, Inc. (004236139)
    Establishment
    Name Address ID/FEI Business Operations
    Kutol Products Company, Inc. 004236139 manufacture(50865-060), analysis(50865-060), label(50865-060), pack(50865-060)
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