SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR CLEAN MINT- potassium nitrate and sodium fluoride paste 
SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR EXTRA FRESH- potassium nitrate and sodium fluoride paste 
SENSODYNE PRONAMEL INTENSIVE ENAMEL REPAIR WHITENING- potassium nitrate and sodium fluoride paste 
GlaxoSmithKline Consumer Healthcare Holdings (US)

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active ingredient

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 of age: Consult a dentist or doctor.

Other information (Clean Mint, Extra Fresh)

store below 25°C (77°F)

Inactive ingredients (Clean Mint)

water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, PVM/MA copolymer, sodium hydroxide

Inactive ingredients (Extra Fresh)

water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, PVM/MA copolymer, sodium hydroxide

Inactive Ingredients (Whitening)

water, sorbitol, hydrated silica, glycerin, PEG-8, sodium lactate, flavor, cocamidopropyl betaine, titanium dioxide, xanthan gum, sodium saccharin, PVM/MA copolymer, sodium hydroxide

Questions or comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC 0135-0492-01

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

CLEAN MINT

ACTIVELY REPAIRS WEAKENED ENAMEL*

NET WT 3.4 OZ (96.4 g)

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

*Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth.

PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

LOCKS IN MINERALS

FOR STRONG HEALTHY TEETH

Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future.

With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to:

•
Actively repair acid-weakened enamel
•
Lock in minerals to protect against the effects of acid wear
•
Protect against cavities

Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

ALWAYS FOLLOW THE LABEL

Trademarks owned or licensed by GSK.

©2018 GSK or licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

62000000030303

Sensodyne Pronamel\62000000030303_Sensodyne Pronamel Intensive Enamel Clean Mint_3.4 OZ.JPG

Principal Display Panel

NDC 0135-0486-01

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

EXTRA FRESH

ACTIVELY REPAIRS WEAKENED ENAMEL*

NET WT 3.4 OZ (96.4 g)

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

*Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth.

PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

LOCKS IN MINERALS

FOR STRONG HEALTHY TEETH

Acids in modern diets can weaken your enamel surface. Over time, this can lead to your enamel thinning, allowing the yellow dull dentin layer underneath to show through. Once your enamel surface is weakened it needs extra care for the future.

With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair helps to:

•
Actively repair acid-weakened enamel
•
Lock in minerals to protect against the effects of acid wear
•
Protect against cavities

Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

ALWAYS FOLLOW THE LABEL

Trademarks owned or licensed by GSK.

©2018 GSK or licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

62000000030306

Sensodyne Pronamel\62000000030306_Sensodyne Pronamel Intensive Enamel Extra Fresh_3.4 OZ.JPG

Principal Display Panel

NDC 0135-0481-01

New

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

WHITENING

ACTIVELY REPAIRS WEAKENED ENAMEL*

NET WT 3.4 OZ (96.4 g)

SENSODYNE

PRONAMEL

INTENSIVE ENAMEL REPAIR

WHITENING

*Sensodyne Pronamel Intensive Enamel Repair is proven to drive minerals deep into the enamel surface to help actively repair acid-weakened areas of the enamel, for stronger, better-protected teeth.

PRONAMEL ACTIVELY REPAIRS WEAKENED ENAMEL

LOCKS IN MINERALS

FOR STRONG HEALTHY TEETH

Actively repairs enamel weakened by dietary acids and helps whiten teeth

With twice-daily brushing, Sensodyne Pronamel Intensive Enamel Repair Whitening helps to:

•
Lock in minerals to protect against the effects of acid wear
•
Protect against cavities
•
Effectively removes stains to whiten teeth
•
Restore natural whiteness of teeth

Sensodyne Pronamel Intensive Enamel Repair is suitable for sensitive teeth.

ALWAYS FOLLOW THE LABEL

Trademarks owned or licensed to the GSK group of companies.

©2019 GSK group of companies or licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

620000000371915

Sensodyne Pronamel Intensive Enamel Repair Whitening
SENSODYNE PRONAMEL  INTENSIVE ENAMEL REPAIR CLEAN MINT
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0492
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)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
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 (Clean Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0492-011 in 1 CARTON11/29/2018
196.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0492-021 in 1 CARTON11/29/2018
223 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0135-0492-0323 g in 1 TUBE; Type 0: Not a Combination Product01/02/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/29/2018
SENSODYNE PRONAMEL  INTENSIVE ENAMEL REPAIR EXTRA FRESH
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0486
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)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
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 (Extra Fresh) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0486-011 in 1 CARTON11/29/2018
196.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0486-022 in 1 CARTON01/06/2020
296.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35611/29/2018
SENSODYNE PRONAMEL  INTENSIVE ENAMEL REPAIR WHITENING
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0481
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)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
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 (Arctic Breeze) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0481-011 in 1 CARTON01/06/2020
196.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0481-022 in 1 CARTON01/06/2020
296.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35601/06/2020
Labeler - GlaxoSmithKline Consumer Healthcare Holdings (US) (079944263)
Establishment
NameAddressID/FEIBusiness Operations
BERNARDY263254254API MANUFACTURE(0135-0492, 0135-0486, 0135-0481)

Revised: 9/2022
Document Id: 770c2c23-3f4e-4209-93c0-315691daea5b
Set id: a2f9d58b-671b-4427-a971-1fceff5f2323
Version: 6
Effective Time: 20220906
 
GlaxoSmithKline Consumer Healthcare Holdings (US)