Label: FRESHMINT SENSITIVE- potassium nitrate and sodium fluoride paste, dentifrice

  • NDC Code(s): 51824-053-01, 51824-053-02
  • Packager: New World Imports, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated November 29, 2023

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

View All Sections
  • Active Ingredients

    Potassium Nitrate - 5%

    Sodium Fluoride - 0.24%

  • Purpose

    Potassium Nitrate - Antihypersensitivity

    Sodium Fluoride - Anticavity


  • Keep out of reach of Children

    If you accidentally swallow more than used for brushing, seek professional help or contact a Poison Control Center immediately.

  • Uses

    Builds increasing protection against painful sensitivity of teeth due to cold, heat, acids, sweets or contact.

    Aids in the prevention of dental cavities

  • Warnings

    When using this product do not use longer than 4 weeks unless recommended by a dentist or doctor

    Stop and ask a dentist if problem persists or worsens.  Sensitive teeth may indicate a serious problem that may require prompt care by a dentist

  • Directions

    Adults and children 12 years and older: Brush teeth for at least one minute, preferably after each meal, or at least twice a day, or as directed by your dentist.  Be sure to brush sensitive areas.  Children under 12 years of age: Consult a dentist or doctor

  • Inactive Ingredients

    Sorbitol, Silica, Treated Water, Polyethylene Glycol 1500, Sodium Lauryl Sulphate, Glycerin, Flavor, Sodium Carboxy Methyl Cellulose, Titanium Dioxide, Tri Sodium Ortho Phosphate, Sodium Saccharin, Sodium Benzoate, Methylparaben, Propylparaben, Color: D and C Yellow # 10, FD and C Blue # 1.

  • PRINCIPAL DISPLAY PANEL

    Toothpaste Image
  • INGREDIENTS AND APPEARANCE
    FRESHMINT SENSITIVE 
    potassium nitrate and sodium fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51824-053
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2.4 mg  in 1 g
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    Sorbitol (UNII: 506T60A25R)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Water (UNII: 059QF0KO0R)  
    Polyethylene Glycol 1500 (UNII: 1212Z7S33A)  
    Sodium Lauryl Sulfate (UNII: 368GB5141J)  
    Glycerin (UNII: PDC6A3C0OX)  
    Carboxymethylcellulose Sodium (UNII: K679OBS311)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Sodium Phosphate, Tribasic, Dodecahydrate (UNII: B70850QPHR)  
    Saccharin Sodium (UNII: SB8ZUX40TY)  
    Sodium Benzoate (UNII: OJ245FE5EU)  
    Methylparaben (UNII: A2I8C7HI9T)  
    Propylparaben (UNII: Z8IX2SC1OH)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Product Characteristics
    Colorgreen (Mint Green) Score    
    ShapeSize
    FlavorMINT (Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51824-053-021 in 1 BOX09/16/2010
    1NDC:51824-053-01122 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph Drugm02109/16/2010
    Labeler - New World Imports, Inc (075372276)
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!