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 
Haleon US Holdings LLC

----------

Drug Facts

Active ingredients

Potassium nitrate 5%

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

Purpose

Antihypersensitivity

Anticavity

Uses

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

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

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:

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:

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:

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:

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)
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)

Revised: 1/2024
Document Id: 0fb8d5cd-17d5-f0ac-e063-6394a90ab28d
Set id: edffce4d-108b-4ffd-9adf-e12cb42ffddd
Version: 21
Effective Time: 20240124
 
Haleon US Holdings LLC