Label: SENSODYNE PRONAMEL CLINICAL ENAMEL STRENGTH DEEP CLEAN- potassium nitrate, sodium fluoride paste

  • NDC Code(s): 0135-0810-01, 0135-0810-02, 0135-0810-03
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated August 14, 2024

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  • Active ingredients

    Potassium nitrate 5%

    Sodium fluoride 0.25% (0.15% w/v fluoride ion)

  • Purposes

    Antihypersensitivity

    Anticavity

  • Uses

    • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
    • aids in the prevention of dental cavities.
  • Warnings

    Stop use and ask a dentist if

    • the problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care by a dentist.
    • pain/sensitivity still persists after 4 weeks of use.

    Keep out of reach of children.

    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 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), and not more than 3 times a day, or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing. Spit out after brushing.
    • children under 12 years of age:Consult a dentist or doctor.
  • Other information

    • do not store above 25°C (77°F)
  • Inactive ingredients

    water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, xanthan gum, cocamidopropyl betaine, sodium methyl cocoyl taurate, silica, titanium dioxide, sodium saccharin, PVM/MA copolymer, sodium hydroxide

  • Questions or comments?

    1-866-844-2797

    ALWAYS FOLLOW THE LABEL

  • Principal Display Panel

    NEW HALEON

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    SENSODYNE

    PRONAMEL CLINICAL ENAMEL STRENGTH

    3X STRONGER ENAMEL PROTECTION*

    # 1 DENTIST RECOMMENDED BRAND FOR ENAMEL EROSION

    DEEP CLEAN

    NET WT 2.3 OZ (65.2 g)

    62000000212484 – Front Carton

    Sensodyne Pronamel Deep Clean 2.3 oz (65.2 g).jpg
  • INGREDIENTS AND APPEARANCE
    SENSODYNE PRONAMEL   CLINICAL ENAMEL STRENGTH DEEP CLEAN
    potassium nitrate, sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0810
    Route of AdministrationORAL
    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 ION1.15 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    SODIUM LACTATE (UNII: TU7HW0W0QT)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYL VINYL ETHER AND MALEIC ACID COPOLYMER (LOW MOLECULAR WEIGHT) (UNII: R2PDK4MI4R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINT (Fresh) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0810-031 in 1 CARTON01/06/2025
    165.2 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0810-021 in 1 CARTON01/06/2025
    296.4 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-0810-0123 g in 1 TUBE; Type 0: Not a Combination Product01/06/2025
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02201/06/2025
    Labeler - Haleon US Holdings LLC (079944263)
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