Label: SECURE- chloroxylenol aerosol, foam

  • 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 April 24, 2012

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  • ACTIVE INGREDIENT



    Active Ingredient   chloroxylenol 0.5%    antiseptic

  • PURPOSE



    Antiseptic
  • KEEP OUT OF REACH OF CHILDREN



    Keep out of reach of children.

  • INDICATIONS & USAGE



    Use: For handwashing to decrease bacteria on the skin.

  • WARNINGS


    Warnings:
    For external use only

    Keep out of reach of children

    Avoid eye contact. Should contact occur, rinse thoroughly with water.

    If swallowed or irritation develops, discontinue use and consult a health care practitioner.

  • DOSAGE & ADMINISTRATION


    Directions:

    Wet hands and forearms with hot water. Apply soap. Rub hands together for 23 seconds. Clean under fingernails. Rinse thoroughly under running water. Dry hands.


  • INACTIVE INGREDIENT

    Inactive Ingredients:
    water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Decyl Glucoside, Cocamide DEA, Glycerin, Fragrance, Citric Acid, DMDM Hydantoin, Yellow 5, Red 4



  • PRINCIPAL DISPLAY PANEL

    label


    Butler Chemicals Inc

    Secure Antibacterial Foam Soap

    Butler Chemicals, Inc

    PH: 800-331-3643www.butlerchem.com

    Chloroxylenol 0.5%  Made in Canada

  • INGREDIENTS AND APPEARANCE
    SECURE 
    chloroxylenol aerosol, foam
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50157-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLOROXYLENOL (UNII: 0F32U78V2Q) (CHLOROXYLENOL - UNII:0F32U78V2Q) CHLOROXYLENOL.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    COCO DIETHANOLAMIDE (UNII: 92005F972D)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    FD&C RED NO. 4 (UNII: X3W0AM1JLX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50157-200-01100 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/24/2011
    Labeler - Brands International (243748238)
    Registrant - Butler Chemicals (165322223)
    Establishment
    NameAddressID/FEIBusiness Operations
    Brands International243748238manufacture
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