Label: DEBMED ANTIMICROBIAL BODY WASH AND SHAMPOO- 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 July 19, 2011

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  • ACTIVE INGREDIENT

    Active ingredient

    Triclosan, 0.70%

  • PURPOSE

    Purpose

    Antimicrobial

  • INDICATIONS & USAGE

    Uses

    For hand and body washing 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 Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    Apply product onto washcloth or directly onto skin

    Lather and wash for 15-20 seconds

    Rinse and dry thoroughly

  • INACTIVE INGREDIENT

    Inactive ingredients

    Water, Disodium Laureth Sulfosuccinate, Sodium Laureth Sulfate, TEA-Dodecylbenzene Sulfonate, Citric Acid, Phenoxyethanol, Hyroxypropyl Guar Hydroxypropyltrimonium Chloride, Aloe Barbadensis Leaf Juice, Sodium Benzoate, Allantoin, Sodium Chloride, Tetrasodium EDTA, Potassium Sorbate, Fragrance, Yellow 5 (CI19140), Red 40 (CI 16035), Blue 1 (CI 42090).

  • PRINCIPAL DISPLAY PANEL

    DebMed Engineering Hand Hygiene Compliance

    AntiMicrobial Body Wash and Shampoo

    1L

    33.8 fl oz

    Made in USA

    DMABHB1L

    container label

  • INGREDIENTS AND APPEARANCE
    DEBMED ANTIMICROBIAL BODY WASH AND SHAMPOO 
    triclosan liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11084-061
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Triclosan (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    DISODIUM LAURETH SULFOSUCCINATE (UNII: D6DH1DTN7E)  
    TEA-DODECYLBENZENESULFONATE (UNII: 8HM7ZD48HN)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GUAR GUM (UNII: E89I1637KE)  
    ALLANTOIN (UNII: 344S277G0Z)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:11084-061-271000 mL in 1 BOTTLE, PLASTIC
    2NDC:11084-061-38222 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2011
    Labeler - Deb USA, Inc. (607378015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb USA, Inc.607378015manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Deb Worldwide Healthcare Inc.205662831manufacture
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