Label: GOLDEN MEDICATED- medicated lotion soap solution

  • NDC Code(s): 50865-060-09, 50865-060-27
  • Packager: Kutol Products Company
  • 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 August 28, 2023

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  • ACTIVE INGREDIENT

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

  • 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.

  • PURPOSE

    Handwash to help decrease bacteria on the skin.

  • WARNINGS

    For external use only.

    Do not usein the eyes. In case of contact, immediately flush with water.

    Stop use and ask a doctor ifirritation or rash appears and lasts.

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

  • 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.
  • 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.

  • 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.

  • PRINCIPAL DISPLAY PANEL

    50865-060-09.jpg50865-060-09.jpg

  • PRINCIPAL DISPLAY PANEL

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

  • INGREDIENTS AND APPEARANCE
    GOLDEN MEDICATED 
    medicated lotion soap solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-060
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    COCONUT ACID (UNII: 40U37V505D)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    SODIUM SULFATE (UNII: 0YPR65R21J)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    TALL OIL ACID (UNII: H9HR63474M)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50865-060-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product03/11/2014
    2NDC:50865-060-271000 mL in 1 BAG; Type 0: Not a Combination Product03/11/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/11/2014
    Labeler - Kutol Products Company (004236139)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company, Inc.004236139manufacture(50865-060)
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