Label: DAWNMIST FLUORIDE- sodium fluoride paste

  • 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 Fluoride Toothpaste

  • Active Ingredient

    Sodium Monofluorophosphate 0.76%

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities.

  • 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.

  • 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 pea sized amount and supervise brushing until good habits are established.

    Children under 2 years: Ask a dentist or physician.

  • Inactive Ingredients

    Sorbitol, Silica, Water, Sodium Lauryl Sulfate, Xanthan Gum, Sodium Benzoate, Titanium Dioxide, Mentha Piperita (Peppermint Oil), Sodium Saccharin

  • DawnMist Fluoride Toothpaste 0.6oz/17g (65517-2018-0)

    DawnMist™ NDC: 65517-2018-0

    ORAL CARE

    Gel Fluoride Toothpaste

    CAVITY FIGHTING FORMULA

    FRESH MINT FLAVOR

    0.6 OZ. (17g)

    mm2

  • INGREDIENTS AND APPEARANCE
    DAWNMIST FLUORIDE 
    sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-2018
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-2018-017 g in 1 TUBE; Type 0: Not a Combination Product01/30/2014
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/30/2014
    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!