Label: DAWNMIST ANTIBACTERIAL - triclosan gel 

  • Label RSS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 03/13

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Triclosan .3%

    Close
  • Purpose

    Antibacterial Agent

    Close
  • Use

    For hand washing to decrease bacteria on skin.

    Close
  • Warnings

    For external use only ■ Do not use in the
    eyes ■ In rare instances of irritation, discontinue use ■ If
    condition persists for more than 72 hours consult a physician
    ■ If swallowed contact a physician or poison control center.

    Close
  • Keep out of reach of children
  • Directions

    To decrease bacteria on skin apply sufficient
    amount to cover hands. Add water, lather and rinse.

    Close
  • Inactive Ingredients

    Water, Sodium Laureth Sulfate,
    Cocamine Oxide, Sodium Chloride, Cocamidopropyl
    Betaine, Propylene Glycol, DMDM Hydantoin, Fra grance,
    FDC Blue #1

    Close
  • Package Label

    DawnMist

    Kills Germs
    and Bacteria
    on Contact

    Melon Scent

    Antibacterial
    Lotion Soap

    8 FL. OZ. (236ml)

    Manufactured for:
    DUKAL CORPORATION
    Ronkonkoma, NY 11779
    (631) 656-3800
    www.dukal.com

    label

    Close
  • INGREDIENTS AND APPEARANCE
    DAWNMIST ANTIBACTERIAL 
    triclosan gel
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65517-1001
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN 3 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SODIUM LAURETH-3 SULFATE  
    COCAMINE OXIDE  
    SODIUM CHLORIDE  
    COCAMIDOPROPYL BETAINE  
    PROPYLENE GLYCOL  
    DMDM HYDANTOIN  
    FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65517-1001-1 236 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 01/10/2013
    Labeler - Dukal Corporation (791014871)
    Close