Label: DAWNMIST DEODORANT - triclosan soap

  • NDC Code(s): 65517-1006-1, 65517-1006-2, 65517-1006-3, 65517-1006-4, view more
    65517-1006-5, 65517-1006-6
  • Packager: Dukal Corporation
  • 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 01/13

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  • Active Ingredient

    Triclosan 0.25%

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  • Purpose

    Antibacterial

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  • Use

    For handwashing to decrease bacteria on skin.

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  • Warning

    For external use only

    • Do not use in eyes
    • Discontinue use if redness or irritation develops
    • Use only as directed
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  • Keep out of reach of children
  • Directions

    Wet bar with water

    Lather vigorously and wash skin

    Rinse and dry thoroughly

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  • Other Ingredients

    Sodium Palmate, Sodium Cocoate, Water, Glycerin, Fragrance, Sodium Chloride , Titanium Dioxide

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  • Package Label

    DawnMist

    Gentle Formula French Milled

    Contains Antibacterial Agent Triclosan

    Lightly Scented

    Deodorant Soap

    Vegetable based product

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

    Reorder No. ASP4128

    Made in USA

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  • INGREDIENTS AND APPEARANCE
    DAWNMIST DEODORANT  
    triclosan soap
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:65517-1006
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    TRICLOSAN (TRICLOSAN) TRICLOSAN .25 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    SODIUM PALMATE  
    SODIUM COCOATE  
    WATER  
    GLYCERIN  
    SODIUM CHLORIDE  
    TITANIUM DIOXIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:65517-1006-1 11 g in 1 PACKAGE
    2 NDC:65517-1006-2 18 g in 1 PACKAGE
    3 NDC:65517-1006-3 25 g in 1 PACKAGE
    4 NDC:65517-1006-4 35 g in 1 PACKAGE
    5 NDC:65517-1006-5 76 g in 1 PACKAGE
    6 NDC:65517-1006-6 127 g in 1 PACKAGE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333E 01/08/2013
    Labeler - Dukal Corporation (791014871)
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