Label: SENSODYNE PRONAMEL GENTLE WHITENING- potassium nitrate and sodium fluoride paste
SENSODYNE PRONAMEL DAILY PROTECTION- potassium nitrate and sodium fluoride paste
SENSODYNE PRONAMEL FRESH BREATH- potassium nitrate and sodium fluoride paste
SENSODYNE PRONAMEL MULTI ACTION- potassium nitrate and sodium fluoride paste

  • NDC Code(s): 0135-0460-01, 0135-0460-03, 0135-0460-06, 0135-0484-01, view more
    0135-0484-02, 0135-0484-03, 0135-0484-04, 0135-0484-05, 0135-0484-06, 0135-0520-01, 0135-0520-02, 0135-0520-05, 0135-0520-06, 0135-0568-04
  • Packager: Haleon US Holdings LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 24, 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

    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 (Gentle Whitening, Daily Protection, Fresh Breath, Multi-Action)

    • do not store above 30°C (86°F)
  • Inactive ingredients (Gentle Whitening)

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

  • Inactive ingredients (Daily Protection)

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

  • Inactive ingredients (Fresh Breath)

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

  • Inactive ingredients (Multi-Action)

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

  • Questions or comments?

    1-866-844-2797

  • Principal Display Panel

    NDC 0135-0484-01

    SENSODYNE

    PRONAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    Alpine Breeze

    GENTLE WHITENING

    Specialist Enamel Protection

    Rebuilds, Restores, Refreshes

    NET WT 4.0 OZ (113g)

    ALWAYS FOLLOW THE LABEL

    SENSODYNE PRONAMEL

    Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

    Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.

    ACID ATTACKS ENAMEL

    WEAKENING THE ENAMEL STRUCTURE

    PRONAMEL REBUILDS & RESTORES ENAMEL

    FOR STRONG HEALTHY TEETH

    Healthy white teeth start with strong enamel.

    Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

    With twice-daily brushing,
    Pronamel helps to:

    • Rebuild enamel strength for strong, healthy teeth
    • Protect against the effects of dietary acids
    • Relieve sensitive teeth
    • Freshen breath
    • Protect against cavities

    Recycle Carton, Tube and Cap†

    Save Water Turn off tap while brushing

    †Recycling facilities for this product may not exist in your area

    Distributed by:

    GSKConsumer Healthcare

    Warren, NJ 07059

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

    ©2021 GSK group of companies or its licensor.

    62000000068970 Front Carton

    Sensodyne Gentle Whitening 6.5 OZ(184 g)
  • Principal Display Panel

    NDC 0135-0460-01

    SENSODYNE

    PRONAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    Mint Essence

    DAILY PROTECTION

    Specialist Enamel Protection

    Rebuilds, Restores, Refreshes

    NET WT 4.0 OZ (113 g)

    ALWAYS FOLLOW THE LABEL

    SENSODYNE PRONAMEL

    Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

    Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.

    ACID ATTACKS ENAMEL

    WEAKENING THE ENAMEL STRUCTURE

    PRONAMEL REBUILDS & RESTORES ENAMEL

    FOR STRONG HEALTHY TEETH

    Healthy white teeth start with strong enamel.

    Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

    With twice-daily brushing,
    Pronamel helps to:

    • Rebuild enamel strength for strong, healthy teeth
    • Protect against the effects of dietary acids
    • Relieve sensitive teeth
    • Freshen breath
    • Protect against cavities

    Recycle Carton, Tube and Cap†

    Save Water Turn off tap while brushing

    †Recycling facilities for this product may not exist in your area

    Distributed by:

    GSKConsumer Healthcare

    Warren, NJ 07059

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

    ©2021 GSK group of companies or its licensor.

    62000000068992 Front Carton

    Sensodyne Daily Protection 4.0 OZ(113 g)
  • Principal Display Panel

    NDC 0135-0520-01

    SENSODYNE

    PRONAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    Fresh Wave

    FRESH BREATH

    Specialist Enamel Protection

    Rebuilds, Restores, Refreshes

    NET WT 4.0 OZ (113 g)

    ALWAYS FOLLOW THE LABEL

    SENSODYNE PRONAMEL

    Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

    Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.

    ACID ATTACKS ENAMEL

    WEAKENING THE ENAMEL STRUCTURE

    PRONAMEL REBUILDS & RESTORES ENAMEL

    FOR STRONG HEALTHY TEETH

    Healthy white teeth start with strong enamel.

    Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

    With twice-daily brushing,
    Pronamel helps to:

    • Rebuild enamel strength for strong, healthy teeth
    • Protect against the effects of dietary acids
    • Relieve sensitive teeth
    • Freshen breath
    • Protect against cavities

    Recycle Carton, Tube and Cap†

    Save Water Turn off tap while brushing

    †Recycling facilities for this product may not exist in your area

    Distributed by:

    GSK Consumer Healthcare

    Warren, NJ 07059

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

    ©2021 GSK group of companies or its licensor.

    62000000068910 Front Carton

    Sensodyne Fresh Breath 4.0 OZ(113 g)
  • Principal Display Panel

    NDC 0135-0568-04

    SENSODYNE

    PRONAMEL

    TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

    Cleansing Mint

    MULTI-ACTION

    Specialist Enamel Protection

    Rebuilds, Restores, Refreshes

    NET WT 4.0 OZ (113 g)

    ALWAYS FOLLOW THE LABEL

    SENSODYNE PRONAMEL

    Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

    Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.

    ACID ATTACKS ENAMEL

    WEAKENING THE ENAMEL STRUCTURE

    PRONAMEL REBUILDS & RESTORES ENAMEL

    FOR STRONG HEALTHY TEETH

    Healthy white teeth start with strong enamel.

    Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

    With twice-daily brushing,
    Pronamel helps to:

    • Rebuild enamel strength for strong, healthy teeth
    • Protect against the effects of dietary acids
    • Relieve sensitive teeth
    • Freshen breath
    • Protect against cavities

    Recycle Carton, Tube and Cap†

    Save Water Turn off tap while brushing

    Distributed by:

    GSKConsumer Healthcare

    Warren, NJ 07059

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

    ©2021 GSK group of companies or its licensor.

    62000000069352 Front Carton

    Sensodyne Multi-Action 4.0 OZ(113 g)
  • INGREDIENTS AND APPEARANCE
    SENSODYNE PRONAMEL   GENTLE WHITENING
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0484
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (alpine breeze) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0484-011 in 1 CARTON10/18/2010
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0484-052 in 1 CARTON10/18/2010
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-0484-021 in 1 CARTON10/18/2010
    376.5 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0135-0484-0322.6 g in 1 TUBE; Type 0: Not a Combination Product10/18/2010
    5NDC:0135-0484-041 in 1 CARTON07/01/2019
    5184.3 g in 1 TUBE; Type 0: Not a Combination Product
    6NDC:0135-0484-064 in 1 CARTON12/16/2014
    6184.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02210/18/2010
    SENSODYNE PRONAMEL   DAILY PROTECTION
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0460
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Mint Essence) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0460-011 in 1 CARTON10/18/2010
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0460-062 in 1 CARTON11/29/2017
    2113 g in 1 TUBE; Type 0: Not a Combination Product
    3NDC:0135-0460-031 in 1 CARTON10/18/2010
    3184.3 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02210/18/2010
    SENSODYNE PRONAMEL   FRESH BREATH
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0520
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (fresh wave) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0520-011 in 1 CARTON04/14/2011
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    2NDC:0135-0520-0223 g in 1 TUBE; Type 0: Not a Combination Product04/14/2011
    3NDC:0135-0520-052 in 1 CARTON04/14/2011
    3113 g in 1 TUBE; Type 0: Not a Combination Product
    4NDC:0135-0520-061 in 1 CARTON03/20/2015
    477 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02204/14/2011
    SENSODYNE PRONAMEL   MULTI ACTION
    potassium nitrate and sodium fluoride paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0568
    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)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    MICA (UNII: V8A1AW0880)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorMINT (Cleansing Mint) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0135-0568-041 in 1 CARTON12/09/2013
    1113 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02212/09/2013
    Labeler - Haleon US Holdings LLC (079944263)