Label: DAWNMIST FLUORIDE- sodium fluoride paste

  • NDC Code(s): 65517-2017-0, 65517-2017-1, 65517-2017-2, 65517-2017-3
  • Packager: Dukal LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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

View All Sections
  • DawnMist Gel Fluoride Toothpaste

  • Active Ingredient

    Sodium Fluoride 0.22%

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities

  • Warning:

  • Keep out of reach of children under 6 years of age

    If you accidently swallow more than used for brushing seek professional assistance or contact a Poison Control immediately

  • Directions

    Adults and children 2 years 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 years: To minimize swallowing, use a peas sized amount and supervisor brushing until good habits are established.

    Children under 2 years: Ask a dentist or physician

  • Inactive Ingredient

    Sorbitol, Water, Silica, Sodium Lauryl Sulphate, PEG1500, Flavor, Carboxymethyl Cellulose, Sodium Benzoate, Sodium Saccharin

  • Principal Display Panel - DawnMist Gel Fluoride Toothpaste 2.75 oz Tube Label

    DawnMist®

    NDC: 65517-2017-0

    ORAL CARE

    Gel Fluoride Toothpaste

    CAVITY FIGHTING FORMULA

    FRESH MINT FLAVOR

    2.75 OZ. (78 g)

    Principal Display Panel - DawnMist Gel Fluoride Toothpaste 2.75 oz Tube Label
  • INGREDIENTS AND APPEARANCE
    DAWNMIST FLUORIDE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-2017
    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
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-2017-078 g in 1 TUBE; Type 0: Not a Combination Product07/14/2017
    2NDC:65517-2017-117 g in 1 TUBE; Type 0: Not a Combination Product07/14/2017
    3NDC:65517-2017-224 g in 1 TUBE; Type 0: Not a Combination Product07/14/2017
    4NDC:65517-2017-343 g in 1 TUBE; Type 0: Not a Combination Product07/14/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/17/2014
    Labeler - Dukal LLC (791014871)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!