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
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NDC Code(s):
0135-0460-01,
0135-0460-03,
0135-0460-06,
0135-0484-01, view more0135-0484-02, 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.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredients
- Purpose
- Uses
- Warnings
-
Directions
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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.
-
adults and children 12 years of age and older:
- Other information (Gentle Whitening, Daily Protection, Fresh Breath, Multi-Action)
- Inactive ingredients (Gentle Whitening)
- Inactive ingredients (Daily Protection)
- Inactive ingredients (Fresh Breath)
- Inactive ingredients (Multi-Action)
- Questions or comments?
-
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
-
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
-
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
-
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
-
INGREDIENTS AND APPEARANCE
SENSODYNE PRONAMEL GENTLE WHITENING
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0484 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.15 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor MINT (alpine breeze) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0484-01 1 in 1 CARTON 10/18/2010 1 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0135-0484-05 2 in 1 CARTON 10/18/2010 2 113 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0135-0484-02 1 in 1 CARTON 10/18/2010 3 76.5 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:0135-0484-03 22.6 g in 1 TUBE; Type 0: Not a Combination Product 10/18/2010 5 NDC:0135-0484-04 1 in 1 CARTON 07/01/2019 5 184.3 g in 1 TUBE; Type 0: Not a Combination Product 6 NDC:0135-0484-06 4 in 1 CARTON 12/16/2014 6 184.3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 10/18/2010 SENSODYNE PRONAMEL DAILY PROTECTION
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0460 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.15 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor MINT (Mint Essence) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0460-01 1 in 1 CARTON 10/18/2010 1 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0135-0460-06 2 in 1 CARTON 11/29/2017 2 113 g in 1 TUBE; Type 0: Not a Combination Product 3 NDC:0135-0460-03 1 in 1 CARTON 10/18/2010 3 184.3 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 10/18/2010 SENSODYNE PRONAMEL FRESH BREATH
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0520 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.15 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor MINT (fresh wave) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0520-01 1 in 1 CARTON 04/14/2011 1 113 g in 1 TUBE; Type 0: Not a Combination Product 2 NDC:0135-0520-02 23 g in 1 TUBE; Type 0: Not a Combination Product 04/14/2011 3 NDC:0135-0520-05 2 in 1 CARTON 04/14/2011 3 113 g in 1 TUBE; Type 0: Not a Combination Product 4 NDC:0135-0520-06 1 in 1 CARTON 03/20/2015 4 77 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 04/14/2011 SENSODYNE PRONAMEL MULTI ACTION
potassium nitrate and sodium fluoride pasteProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0135-0568 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE 50 mg in 1 g SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION 1.15 mg in 1 g Inactive Ingredients Ingredient Name Strength 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 Color white Score Shape Size Flavor MINT (Cleansing Mint) Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0135-0568-04 1 in 1 CARTON 12/09/2013 1 113 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M022 12/09/2013 Labeler - Haleon US Holdings LLC (079944263)