Label: SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL MINT- potassium nitrate and sodium fluoride paste
SENSODYNE PRONAMEL STRONG AND BRIGHT ENAMEL EXTRA FRESH- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 0135-0602-01, 0135-0602-02, 0135-0603-01
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated March 6, 2024

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

  • Active ingredients

    Potassium nitrate 5%

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

  • Purpose

    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

    When using this product,

    if irritation occurs discontinue use.

    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

    Consult a dentist or doctor.

  • Other information

    store below 25°C (77°F)

  • Inactive ingredients

    water, hydrated silica, sorbitol, glycerin, PEG-8, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

  • Questions or comments?

    Call toll-free 1-866-844-2797

  • Principal Display Panel

    NDC 0135-0602-01

    SENSODYNE

    PRONAMEL

    STRONG & Bright

    ENAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    STRONGENAMEL

    WHITERTEETH*

    MINT

    No. 1 DENTIST RECOMMENDED BRAND

    FOR STRENGTHENING AND PROTECTING ENAMEL

    *vs. ProNamel Daily Protection

    NET WT 3.0 OZ (85 g)

    Enamel is the vital layer of protection for your teeth and keeping it strong is so important.

    Sensodyne ProNamel STRONG & BrightENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids.

    *vs. ProNamel Daily Protection

    With twice daily brushing, the dual action formulation:

    • Delivers minerals into the enamel to help STRENGTHEN & PROTECT.
    • Polishes away stains for WHITER BRIGHTER TEETH.

    FRESHENSbreath and fights CAVITIES

    GSKConsumer Healthcare

    Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2017 GSK group of companies or its licensor

    ALWAYS FOLLOW THE LABEL

    105491XC 105491XC_ProNamel Strong & Bright_3.0 oz.JPG

  • Principal Display Panel

    NDC 0135-0603-01

    SENSODYNE

    PRONAMEL

    STRONG & Bright

    ENAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    STRONGENAMEL

    WHITERTEETH*

    EXTRA FRESH

    No. 1 DENTIST RECOMMENDED BRAND

    FOR STRENGTHENING AND PROTECTING ENAMEL

    *vs. ProNamel Daily Protection

    NET WT 3.0 OZ (85 g)

    Enamel is the vital layer of protection for your teeth and keeping it strong is so important.

    Sensodyne ProNamelSTRONG & BrightENAMEL gives you whiter teeth* while actively helping to strengthen your tooth enamel and protect against everyday acids.

    *vs. ProNamel Daily Protection

    With twice daily brushing, the dual action formulation:

    • Delivers minerals into the enamel to help STRENGTHEN & PROTECT.
    • Polishes away stains for WHITER BRIGHTER TEETH.

    FRESHENSbreath and fights CAVITIES

    GSKConsumer Healthcare

    Warren, NJ 07059

    Trademarks are owned by or licensed to the GSK group of companies.

    ©2017 GSK group of companies or its licensor.

    ALWAYS FOLLOW THE LABEL

    105488XC

    105488XC_ProNamel Strong and Bright Enamel Extra Fresh_3 oz.JPG
  • INGREDIENTS AND APPEARANCE
    SENSODYNE PRONAMEL  STRONG AND BRIGHT ENAMEL MINT
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0602
    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)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0602-011 in 1 CARTON12/19/2016
    185 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0602-021 in 1 CARTON12/19/2016
    223 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/19/2016
    SENSODYNE PRONAMEL   STRONG AND BRIGHT ENAMEL EXTRA FRESH
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0603
    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)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    SORBITOL (UNII: 506T60A25R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0603-011 in 1 CARTON12/19/2016
    185 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/19/2016
    Labeler - Haleon US Holdings LLC (079944263)