Label: SOFT AND SILKY ANTISEPTIC- antiseptic lotion soap solution

  • NDC Code(s): 50865-025-03, 50865-025-07, 50865-025-09, 50865-025-12, view more
    50865-025-18, 50865-025-65, 50865-025-80, 50865-025-82, 50865-025-93
  • Packager: Kutol Products Company, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated December 18, 2024

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  • ACTIVE INGREDIENT

    Chloroxylenol 0.1% w/w...........Antibacterial Handwashing

  • INACTIVE INGREDIENT

    Water, Tall Oil Acid, Potassium Hydroxide, Coconut Acid, Sodium Lauryl Sulfate, Cocamide DIPA, Phenoxyethanol, Tetrasodium EDTA, Sodium Chloride, Styrene/Acrylates Copolymer, Fragrance, Iodopropynyl Butylcarbamate.

  • PURPOSE

    Handwash to help decrease bacteria on the skin.

    USDA E-1

  • 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.

  • 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.

    USDA E-1

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

    Stop use and ask a doctor if irritation or redness 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

    50865-025-65.jpg 50865-025-65.jpg

  • INGREDIENTS AND APPEARANCE
    SOFT AND SILKY ANTISEPTIC 
    antiseptic lotion soap solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50865-025
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL3.82 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    METHACRYLATE/METHOXY PEG-10 MALEATE/STYRENE COPOLYMER (UNII: 39DK5WQ2PR)  
    FRAGRANCE FLORAL ORC0902236 (UNII: R66Z4YW3X0)  
    WATER (UNII: 059QF0KO0R)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    TALL OIL (UNII: 1GX6Z36A79)  
    COCONUT ACID (UNII: 40U37V505D)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIISOPROPANOLAMIDE (UNII: S485AM948Q)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50865-025-03208175 mL in 1 DRUM; Type 0: Not a Combination Product11/04/2013
    2NDC:50865-025-073785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/201305/10/2017
    3NDC:50865-025-093785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/2013
    4NDC:50865-025-121200 mL in 1 BAG; Type 0: Not a Combination Product11/04/201305/10/2017
    5NDC:50865-025-18500 mL in 1 BAG; Type 0: Not a Combination Product11/04/2013
    6NDC:50865-025-65800 mL in 1 BAG; Type 0: Not a Combination Product11/04/2013
    7NDC:50865-025-80800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/201305/10/2017
    8NDC:50865-025-82800 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/201305/10/2017
    9NDC:50865-025-931200 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/04/201305/10/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drug505G(a)(3)11/04/2013
    Labeler - Kutol Products Company, Inc. (004236139)
    Registrant - Kutol Products Company (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company Inc.004236139manufacture(50865-025)
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