Label: SODIUM FLUORIDE- toothpaste cream

  • NDC Code(s): 65517-2000-0, 65517-2000-1, 65517-2000-2, 65517-2000-3, view more
    65517-2000-4, 65517-2000-5, 65517-2000-6, 65517-2000-7
  • Packager: DUKAL LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 13, 2023

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  • Active ingredient

    Sodium fluoride 0.22%

  • Purpose

    Anticavity 

  • Use

    aids in the prevention of dental cavities  

  • Warnings Section

    Warnings

    Keep out of reach of children

    Keep out of reach of children under six years of age. If you accidently 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 doctor or physician.

  • Inactive ingredients

    calcium carbonate,water,sorbitol, sodium lauryl sulfate, silica, carboxymethyl cellulose, flavor, potassium nitrate, sodium benzoate, sodium saccharin, menthol

  • Expiration date

    Expiration date & batch No. on crimp of tube

  • Principal Display Panel - DawnMist Fluoride Toothpaste 0.6 OZ Tube Label

    DawnMist®

    NDC: 65517-2000-0

    ORAL CARE

    Fluoride Toothpaste

    CAVITY FIGHTING FORMULA

    FRESH MINT FLAVOR

    0.6 OZ. (17 g)

    Principal Display Panel - DawnMist Fluoride Toothpaste 0.6 OZ Tube Label
  • INGREDIENTS AND APPEARANCE
    SODIUM FLUORIDE 
    toothpaste cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:65517-2000
    Route of AdministrationORAL
    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
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    POTASSIUM NITRATE (UNII: RU45X2JN0Z)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MENTHOL (UNII: L7T10EIP3A)  
    Product Characteristics
    Colorwhite (White) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:65517-2000-017 g in 1 TUBE; Type 0: Not a Combination Product02/19/2015
    2NDC:65517-2000-124 g in 1 TUBE; Type 0: Not a Combination Product02/19/2015
    3NDC:65517-2000-242 g in 1 TUBE; Type 0: Not a Combination Product02/19/2015
    4NDC:65517-2000-378 g in 1 TUBE; Type 0: Not a Combination Product02/19/2015
    5NDC:65517-2000-41 in 1 BOX02/19/2015
    542 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:65517-2000-51 in 1 BOX02/19/2015
    678 g in 1 TUBE; Type 0: Not a Combination Product
    7NDC:65517-2000-61 in 1 BOX02/19/2015
    7135 g in 1 TUBE; Type 0: Not a Combination Product
    8NDC:65517-2000-71 in 1 BOX02/19/2015
    8181 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02211/13/2013
    Labeler - DUKAL LLC (791014871)
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