Label: MADE BY DENTISTS ENAMEL REBUILDING FRESH MINT- potassium nitrate, sodium fluoride paste

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

Drug Label Information

Updated February 27, 2024

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  • Drug Facts

  • Active ingredient:

    Potassium Nitrate 5.0%

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

    Purpose

    Antisensitivity

    Anticavity 

  • Use:

    Aids in the prevention of cavities. Helps reduce painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.

  • Warnings:

    Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or doctor.

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

    If more than used for brushing is accidentlly swallowed, get medical help or contact a Poison Control Center right away.

  • Directions:

    • Adults and children 12 years of age and older: Apply at least a 1-inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly, for at least 1 minute twice a day, (morning and evening) or as recommended by a dentist or doctor.
    • Make sure to brush all sensitive areas of the teeth.
    • Children under 12 years of age: Consult a dentist or doctor.
  • Inactive ingredients:

    Cellulose Gum, Cocamidopropyl Betaine, Flavor, Hydrated Silica, Hydroxyapatite, Pentasodium Triphosphate, Potassium Sorbate, Sodium Bicarbonate, Sodium Saccharin, Sorbitol, Titanium Dioxide, Water (Aqua), Xylitol

  • Questions or comments?

    + 1 (646) 980-6461

  • Label

    Labell.jpgLabel2.jpg

  • INGREDIENTS AND APPEARANCE
    MADE BY DENTISTS ENAMEL REBUILDING FRESH MINT 
    potassium nitrate, sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75065-028
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SODIUM TRIPOLYPHOSPHATE ANHYDROUS (UNII: 9SW4PFD2FZ)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SORBITOL (UNII: 506T60A25R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75065-028-061 in 1 CARTON02/22/2024
    1120 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02202/22/2024
    Labeler - MADE BY DENTISTS INC (117405870)
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