Label: DEB MED ANTIBACTERIAL FOAM HAND WASH- triclosan liquid

  • 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 February 2, 2012

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  • ACTIVE INGREDIENT

    Active ingredient

    Triclosan, 0.30%

  • PURPOSE

    Purpose

    Antibacterial

  • INDICATIONS & USAGE

    Uses

    For handwashing to reduce bacteria on the skin

  • WARNINGS

    Warnings

    For external use only

    When using this product avoid contact with eyes.

    In case of eye contact, flush with water.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply foam cleanser to dry hands.

    Rub hands together to spread lather

    Wash for 15-20 seconds

    Rinse and dry hands thoroughly

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Sodium Laureth Sulfate, Propylene Glycol, PPG-24-Glycereth-24, Cocamidopropyl Betaine, Tetrasodium EDTA, 2-bromo-2-nitropropane-1,3-diol, Fragrance, Citric Acid, Green 5 (CI 61570), Yellow 5 (CI 19140)

  • PRINCIPAL DISPLAY PANEL

    deb med

    Engineering Hand Hygiene Compliance

    Antibacterial Foaming Hand Soap

    Meets Protocol for Healthcare Personnel Handwash

    1L  33.8 fl. oz.

    DMAB1L

    Antibacterial Foam Wash

    Rev. 12-11

    Made in USA

    Deb, Charlotte, NC 28217

    1-800-248-7190

    www.debgroup.com

    container label


  • INGREDIENTS AND APPEARANCE
    DEB MED ANTIBACTERIAL FOAM HAND WASH 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (TRICLOSAN - UNII:4NM5039Y5X) TRICLOSAN0.30 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-116-271000 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A12/15/2011
    Labeler - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb USA, Inc.607378015manufacture
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