Label: MADA MEDICAL FOAM SANITIZER- benzethonium chloride liquid

  • Category: HUMAN OTC DRUG LABEL

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 July 12, 2011

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  • ACTIVE INGREDIENT

    Benzethonium chloride 0.2 %

  • PURPOSE

    Hand sanitizer to help reduce bacteria on the skin that could cause disease.  Recommended for repeated use.

  • KEEP OUT OF REACH OF CHILDREN

    If swallowed, get medical help or contact a poison control center.

    To decrease bacteria on skin, apply small amount of product to palms.  Briskly rub, covering hands with product until dry.

    For external use only.  Avoid contact with eyes.  If contact occurs, flush with water.

  • DOSAGE & ADMINISTRATION

    To decrease bacteria on skin, apply small amount to palm.  Briskly rub, covering hands with product until dry.  Children should be supervised when using product.

    Water, Fragrance, Aloe Barbadensis, Tocopheryl Acetate, Cocamidopropyl Betaine, PEG-7 Glyceryl Cocoate, Propylene Glycol, Phenoxyethanol, Tetrasodium EDTA

  • PRINCIPAL DISPLAY PANEL

    Foaming Instant Hand Sanitizer Bag Label

    Mada Medical Foaming IHS label

  • INGREDIENTS AND APPEARANCE
    MADA MEDICAL  FOAM SANITIZER
    benzethonium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11928-682
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Benzethonium Chloride (UNII: PH41D05744) (Benzethonium - UNII:1VU15B70BP) Benzethonium Chloride0.2 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    Edetate Sodium (UNII: MP1J8420LU)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Aloe Vera Flower (UNII: 575DY8C1ER)  
    .ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N)  
    Glyceryl Cocoate (UNII: WVK1CT5994)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11928-682-411000 mL in 1 BAG
    2NDC:11928-682-1750 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/02/2010
    Labeler - Mada Medical (048411862)
    Registrant - Kutol Products Company, Inc. (004236139)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kutol Products Company, Inc.004236139manufacture
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