Label: FRESHEN UP- sodium fluoride, potassium nitrate gel, dentifrice

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated June 12, 2025

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Sodium fluoride 0.24% (0.15% w/v fluoride ion)

    Potassium Nitrate 5%

  • Purpose

    Anticavity

    Antihypersensitivity

  • Use

    builds increasing protection against painful sensitivity of teeth to cold, heat, acids, sweets or contact

    aids in prevention of dental cavities

  • Warnings

    Stop use and ask a dentist if the problem persists or worsens, snesitive teeth may indicate a serious problem that may need prompt care by dentist. Pain senstivity still persists after 4 weeks of use

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

  • Directions

    adults and children 12 years of age and olderapply atleast a 1-inch strip of paste onto a soft bristle toothrush. bursh atleast for 2 minutes preferably after each meal or at least twice a day, or as directed by a dentist or physician. Make sure to brush all sensitve areas of the teeth. minimizi swallowing. Spit out after brushing
    children under 12 years and underask a dentist or physician
  • Inactive ingredients

    sorbitol, water, hydrated silica, PEG-32, sodium lauryl sulfate, flavor, tetrasodium pyrophosphate, cellulose gum, xlitol, sodium saccharin,titanium dioxide, benzyl alcohol,Tri sodium phosphate, sodium benzoate

  • Questions?

    1-888-880-1504

  • SPL UNCLASSIFIED SECTION

    Dist. by:
    MKJ Brands

  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    FRESHEN UP 
    sodium fluoride, potassium nitrate gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77782-002
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION24 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    SODIUM SACCHARIN (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    WATER (UNII: 059QF0KO0R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    PEG-32 (UNII: 1212Z7S33A)  
    CELLULOSE GUM (UNII: K679OBS311)  
    TETRASODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
    SODIUM PHOSPHATE, TRIBASIC, ANHYDROUS (UNII: SX01TZO3QZ)  
    XYLITOL (UNII: VCQ006KQ1E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77782-002-13113 g in 1 BOTTLE; Type 0: Not a Combination Product02/10/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02102/10/2025
    Labeler - MKJ BRANDS LLC (827648101)
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