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DawnMist (Donovan Industries, Inc.)

Available Formats

Dosage Form Package Information Links
PASTE 2.83 g in 1 KIT (55504-0540-2) Label Information
PASTE 2.83 g in 1 KIT (55504-0540-1) Label Information
PASTE 3 g in 1 TUBE (55504-0540-3) Label Information

Complete DawnMist Information

  • ACTIVE INGREDIENT


    DRUG FACTS

    Active Ingredient:                                                   Purpose:
    SMFP 0.76% ......................................................... Anticavity

  • PURPOSE

    Use: Aids in the prevention of dental cavities


  • WARNINGS

    Warning: Keep out of reach of children under 6 years of age.

    If you accidentally swallow more than used for brushing seek

    professional assistance or contact a Poison Control Center Immediately.


  • INACTIVE INGREDIENT

    Directions : Adults and children 2 yrs. and older. Brush teeth thoroughly after

    meals or at least twice a day or use as directed by a dentist or physician.

    Children under 6 yrs.: To minimize swallowing use a pea sized amount and

    supervise brushing until good habits are established.

    Children Under 2 years: Ask a dentist or physician.


  • DESCRIPTION

    Sorbitol, Silica, Water, Sodium Lauryl Sulfate,

    Xanthan Gum, Sodium Benzoate, Titanium Dioxide,

    Peppermint Oil, Sodium Saccharin


  • DESCRIPTION

    Expiration Date: Expiration Date and Batch No. on Primary Package


  • DESCRIPTION

    Manufactured for:

    Donovan Industries, Inc.

    Tampa, FL 33626-3061

    www.dawnmist.com

    1-800-334-4404

    MADE IN MALAYSIA


  • PRINCIPAL DISPLAY PANEL

    DawnMist

    Cavity Fighting

    Formula

    Mint Flavor

    Toothbrush, Toothpaste and Floss Kit

    100 Kits Each Net Wt  .1 OZ 3g



    CONTAINS ONE TOOTHBRUSH, ONE TUBE

    OF TOOTHPASTE AND ONE FLOSS


  • INGREDIENTS AND APPEARANCE
    DAWNMIST 
    toothbrush, toothpaste and floss kit paste
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55504-0540
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE 0.76 g  in 3 g
    Inactive Ingredients
    Ingredient Name Strength
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SACCHARIN (UNII: FST467XS7D)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55504-0540-1 2.83 g in 1 KIT
    2 NDC:55504-0540-2 2.83 g in 1 KIT
    3 NDC:55504-0540-3 3 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part355 09/01/2009
    Labeler - Donovan Industries, Inc. (096662267)
    Registrant - Fulijaya Manufacturing SDN. BHD. (652087115)
    Establishment
    Name Address ID/FEI Business Operations
    Fulijaya Manufacturing SDN. BHD. 652087115 manufacture
    Establishment
    Name Address ID/FEI Business Operations
    Donovan Industries, Inc. 096662267 import