Label: DIAL MOUNTAIN FRESH ANTIBACTERIAL BODY WASH- triclosan solution

  • 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 14, 2011

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  • ACTIVE INGREDIENT


    Active Ingredient - Triclosan 0.15%
  • PURPOSE

    Antibacterial

  • INDICATIONS & USAGE

    For hand washing to decrease bacteria on the skin

  • WARNINGS

    For external use only

  • WHEN USING

    Avoid contact with eyes.  In case of eye contact, flush with water.

  • ASK DOCTOR

    Stop use and ask a doctor if irritation and redness develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions

    • Squeeze onto hands or body sponge
    • Work into lather
    • Wash skin, rinse thoroughly and dry
  • INACTIVE INGREDIENT

    Water, sodium laureth sulfate, cocamidopropyl betaine, PEG-8, fragrance, glycerin, polyquaternium-10, cocamidopropyl PG-dimonium chloride, isostearamidopropyl morpholine lactate, sodium chloride, DMDM hydantoin, citric acid, tetrasodium EDTA, green 5, yellow 5.
  • QUESTIONS

    Questions? 1-800-258-DIAL (3425)

  • PRINCIPAL DISPLAY PANEL

    label image

  • INGREDIENTS AND APPEARANCE
    DIAL MOUNTAIN FRESH ANTIBACTERIAL BODY WASH 
    triclosan solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54340-179
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TRICLOSAN (UNII: 4NM5039Y5X) (Triclosan - UNII:4NM5039Y5X) Triclosan0.15 mL  in 1000 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
    CHLORIDE ION (UNII: Q32ZN48698)  
    MORPHOLINE (UNII: 8B2ZCK305O)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    FD&C YELLOW NO. 5 (UNII: I753WB2F1M)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54340-179-01355 mL in 1 BOTTLE, PLASTIC
    2NDC:54340-179-02532 mL in 1 BOTTLE, PLASTIC
    3NDC:54340-179-03621 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/01/2011
    Labeler - The Dial Corporation (070252531)
    Establishment
    NameAddressID/FEIBusiness Operations
    The Dial Corporation West Hazelton825091622manufacture
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