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 
Haleon US Holdings LLC

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Drug Facts

Active ingredients

Potassium nitrate 5%

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

Purpose

Antihypersensitivity

Anticavity

Uses

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:

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:

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
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)

Revised: 3/2024
Document Id: 13097a10-0813-22b5-e063-6294a90a9317
Set id: be1ae382-0e01-4db8-90d7-fdadec2ff861
Version: 4
Effective Time: 20240306
 
Haleon US Holdings LLC