Label: DAWNMIST GEL FLUORIDE- gel fluoride toothpaste gel, dentifrice

  • NDC Code(s): 65517-2004-0, 65517-2004-1, 65517-2004-2, 65517-2004-3
  • Packager: Dukal LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 22, 2024

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  • DawnMist Gel Fluoride Toothpaste

  • ACTIVE INGREDIENT

    Sodium Fluoride 0.22%

  • PURPOSE

    Anticavity

  • INDICATIONS & USAGE

    Aids in the prevention of dental cavities.

  • WARNINGS

    Keep out of the reach of children under 6 years of age.

    Keep out of the reach of children under 6 years of age. If more than used for brushing is accidently swallowed, get medical help or contact a Poison Control Center immediately.

  • DOSAGE & ADMINISTRATION

    Do not swallow, supervise children as necessary until capable of using without supervision. Instruct Children under 12 years of age in good brushing and rinsing habits (to minimize swallowing). Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Children under 6 years of age: Do not use unless directed by a doctor or dentist.

  • INACTIVE INGREDIENT

    Sorbitol, Hydrated Silica, Glycerin, Water, PEG-400, Sodium Lauryl Sulfate, Cellulose Gum, Flavor, Sodium Benzoate, Xanthan Gum, Sodium Saccharin

  • PRINCIPAL DISPLAY PANEL

    DawnMist NDC: 65517-2004-1

    Oral Care

    Gel Fluoride Toothpaste

    FRESH MINT FLAVOR

    0.6 OZ. (17 g)

    GTP6454

  • PRINCIPAL DISPLAY PANEL

    DawnMist NDC: 65517-2004-2

    Oral Care

    Gel Fluoride Toothpaste

    FRESH MINT FLAVOR

    0.85 OZ. (24 g)

    GTP4661

  • PRINCIPAL DISPLAY PANEL

    DawnMist NDC: 65517-2004-3

    Oral Care

    Gel Fluoride Toothpaste

    FRESH MINT FLAVOR

    1.5 OZ. (43 g)

    GTP4678

  • PRINCIPAL DISPLAY PANEL

    DawnMist NDC: 65517-2004-0

    Oral Care

    Gel Fluoride Toothpaste

    FRESH MINT FLAVOR

    2.75 OZ. (78 g)

    GTP4685

  • INGREDIENTS AND APPEARANCE
    DAWNMIST GEL FLUORIDE 
    gel fluoride toothpaste gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-2004
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    WATER (UNII: 059QF0KO0R)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-2004-117 g in 1 TUBE; Type 0: Not a Combination Product05/01/2024
    2NDC:65517-2004-078 g in 1 TUBE; Type 0: Not a Combination Product05/01/2024
    3NDC:65517-2004-224 g in 1 TUBE; Type 0: Not a Combination Product05/01/2024
    4NDC:65517-2004-343 g in 1 TUBE; Type 0: Not a Combination Product05/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02105/01/2024
    Labeler - Dukal LLC (791014871)
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