WINNING HANDS ALCOHOL FREE (BENZALKONIUM CHLORIDE) SOAP [BETCO CORPORATION, LTD.]

WINNING HANDS ALCOHOL FREE (BENZALKONIUM CHLORIDE) SOAP [BETCO CORPORATION, LTD.]
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NDC 65601-752-04, 65601-752-54, 65601-752-55
Set ID c9607cbc-2da9-4bb2-b141-30988f766e5b
Category HUMAN OTC DRUG LABEL
Packager Betco Corporation, Ltd.
Generic Name
Product Class
Product Number
Application Number PART333A
  • Winning Hands Alcohol Free

    ​Active Ingredient

    Benzalkonium Chloride 0.13%

  • Winning Hands Alcohol Free

    Uses

    • Use in a variety of public facilities.
    • Use this product when soap and water are not available.
  • Winning Hands Alcohol Free

    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 Alcohol Free

    Directions

    • ​Read the entire label before using this product.
    • ​Dispense product onto dry hands. Rub hands together until hands are dry.
    • Use as needed between hand washes to reduce bacteria on the skin.
  • Winning Hands Alcohol Free

    Inactive Ingredients

    Deionized ​Water, Sodium PCA, PEG/PPG-8/3 Laurate, Dimethicone, DMDM Hydantoin, PEG-3 Cocamide, Fragrance, Iodoproynyl Btylcarbamate, D&C Green #5.

  • Winning Hands Alcohol Free

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

    MDS information:​(800) 891-4965

  • Winning Hands Alcohol Free

    Purpose

    Antiseptic

  • Winning Hands Alcohol Free

    KEEP OUT OF REACH OF CHILDREN

  • Winning Hands Alcohol Free

    Winning Hands Alcohol Free

    Nondrying-Nonflammable Alcohol Free Foaming Hand Sanitizer

    Net Contents: 1 gallon (U.S./E.U.) 3.78 L

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  • INGREDIENTS AND APPEARANCE
    WINNING HANDS ALCOHOL FREE 
    benzalkonium chloride soap
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65601-752
    Route of AdministrationTopical
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE1.3 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM PYRROLIDONE CARBOXYLATE (UNII: 469OTG57A2)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    PEG-6 COCAMIDE (UNII: YZ6NLA4O1E)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65601-752-043780 mL in 1 JUG; Type 0: Not a Combination Product11/12/201201/01/2016
    2NDC:65601-752-541000 mL in 1 BAG; Type 0: Not a Combination Product11/12/201201/01/2016
    3NDC:65601-752-55207900 mL in 1 DRUM; Type 0: Not a Combination Product11/12/201201/01/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A11/12/2012
    Labeler - Betco Corporation, Ltd. (070307547)
    Registrant - Betco corporation, Ltd. (070307547)
    Establishment
    NameAddressID/FEIBusiness Operations
    Betco Corporation, Ltd.070307547manufacture(65601-752)

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