Label: DAWNMIST- toothbrush, toothpaste and floss kit paste

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph 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 August 18, 2009

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  • 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

  • PRINCIPAL DISPLAY PANEL

    Donovan Kit

  • PRINCIPAL DISPLAY PANEL

    Fulijaya Kit Part 1

  • PRINCIPAL DISPLAY PANEL

    Fulijaya Kit Part 2

  • INGREDIENTS AND APPEARANCE
    DAWNMIST 
    toothbrush, toothpaste and floss kit paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55504-0540
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM MONOFLUOROPHOSPHATE0.76 g  in 3 g
    Inactive Ingredients
    Ingredient NameStrength
    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 CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55504-0540-12.83 g in 1 KIT
    2NDC:55504-0540-22.83 g in 1 KIT
    3NDC:55504-0540-33 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35509/01/2009
    Labeler - Donovan Industries, Inc. (096662267)
    Registrant - Fulijaya Manufacturing SDN. BHD. (652087115)
    Establishment
    NameAddressID/FEIBusiness Operations
    Fulijaya Manufacturing SDN. BHD.652087115manufacture
    Establishment
    NameAddressID/FEIBusiness Operations
    Donovan Industries, Inc.096662267import
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