WINNING HANDS PREMIUM ANTIBACTERIAL (CHLOROXYLENOL) SOAP [BETCO CORPORATION, LTD.]

WINNING HANDS PREMIUM ANTIBACTERIAL (CHLOROXYLENOL) SOAP [BETCO CORPORATION, LTD.]
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NDC 65601-736-04, 65601-736-10, 65601-736-19
Set ID c6606ee0-f332-421f-bf2f-81b4bd0a869d
Category HUMAN OTC DRUG LABEL
Packager Betco Corporation, Ltd.
Generic Name
Product Class
Product Number
Application Number PART333A
  • Winning Hands Premium Antibacterial

    ​Active Ingredient

    ​Chloroxylenol 0.5%

  • Winning Hands Premium Antibacterial

    Uses

    • ​Antibacterial hand cleaner.
    • Use in daycare, hospitals, nursing homes, physicians offices, dental offices and clinics
  • Winning Hands Premium Antibacterial

    Warnings

    • For external use only.
    • Avoid contact with eyes.
    • Children under the age of 6 should be supervised by an adult when using this product.
    • Discontinue use is irritation or redness develops.
    • If irritation persists for more than 72 hours, consult a physician.
    • KEEP OUT OF REACH OF CHILDREN.
  • Winning Hands Premium Antibacterial

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense 1-2 pumps of product onto wet palm.
    • Lather and rinse hands with clean water
  • Winning Hands Premium Antibacterial

    Inactive Ingredients

    ​Water, Sodium Lauryl lSulfate, Coco Diethanolimide, Cocamidopropyl Betaine, Phenoxyethanol, Sodium Laureth Sulfate, Allantoin, DMDM Hydantoin, Fragrance, Aloe Barbadensis Leaf Juice, Glycerine, FD&C Yellow #5, FD&C Red #40.

  • Winning Hands Premium Antibacterial

    Questions or Comments?Phone: (800) 777-9343

    MDS information:​(800) 891-4965

  • Winning Hands Premium Antibacterial

    Purpose

    Antibacterial

  • Winning Hands Premium Antibacterial

    KEEP OUT OF REACH OF CHILDREN

  • Winning Hands Premium Antibacterial

    Winning Hands Premium Antibacterial

    SKIN CLEANSER

    Premium Antibacterial Skin Cleanser with Chloroxylenol (PCMX), Aloe and Allantoin

    Net Contents: 30.4 fl. oz. (900 mL)

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  • INGREDIENTS AND APPEARANCE
    WINNING HANDS PREMIUM ANTIBACTERIAL 
    chloroxylenol soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-736
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL5.0 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-736-19900 mL in 1 BAG
    2NDC:65601-736-101100 mL in 1 BAG
    3NDC:65601-736-043780 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/12/2012
    Labeler - Betco Corporation, Ltd. (005050158)
    Registrant - Betco corporation, Ltd. (005050158)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corpo, Ltd.005050158manufacture(65601-736)

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