SENSODYNE PRONAMEL  ACTIVE SHIELD FRESH MINT- potassium nitrate and sodium fluoride paste 
SENSODYNE PRONAMEL  ACTIVE SHIELD COOL MINT- potassium nitrate and sodium fluoride paste 
Haleon US Holdings LLC

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Drug Facts

Active ingredient

Potassium nitrate 5%

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

Purposes

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

Inactive ingredients

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

Questions or comments?

1-866-844-2797

Additional information (Fresh Mint)

SENSODYNE PRONAMEL ACTIVE SHIELD

No 1 dentist recommended brand for enamel protection & strengthening.

Enamel is your natural defense shield for healthy teeth. Everyday it can be weakened by dietary or sugar acids which make your teeth more at risk to cavities and enamel wear.

New Pronamel Active Shield – start building resistance today to help keep your teeth strong and healthy for life.**

Acids from foods, drinks or sugars weaken the enamel surface

Pronamel has a proven formula that actively reinforces weakened enamel

Proven to actively reinforce weakened enamel

Developed for defense against cavities and enamel wear by remineralizing your weakened enamel. Pronamel Active Shield helps with:

2X stronger resistance against dietary acids from Day 1*

Helps shield the enamel against erosion and cavities

Enhanced foaming action# with extra fresh mint to leave the whole mouth feeling clean and fresh

*vs your mouth’s natural defenses

** With continued twice daily brushing, a healthy diet and regular dental visits.

#vs Pronamel Daily Protection

ALWAYS FOLLOW THE LABEL

Trademarks owned or licensed by GSK. ©2022 GSK or licensor.

Distributed by: GSK Consumer Healthcare,Warren, NJ 07059

Additional information (Cool Mint)

S ENSODYNE PRONAMEL ACTIVE SHIELD

No 1 dentist recommended brand for enamel protection & strengthening.

Enamel is your natural defense shield for healthy teeth. Everyday it can be weakened by dietary or sugar acids which make your teeth more at risk to cavities and enamel wear.

New Pronamel Active Shield – start building resistance today to help keep your teeth strong and healthy for life.**

Acids from foods, drinks or sugars weaken the enamel surface

Pronamel has a proven formula that actively reinforces weakened enamel

Proven to actively reinforce weakened enamel

Developed for defense against cavities and enamel wear by remineralizing your weakened enamel. Pronamel Active Shield helps with:

2X stronger resistance against dietary acids from Day 1*

Helps shield the enamel against erosion and cavities

Enhanced foaming action# with extra fresh mint to leave the whole mouth feeling clean and fresh

Effectively and gently removes stains for whiter teeth

*vs your mouth’s natural defenses

** With continued twice daily brushing, a healthy diet and regular dental visits.

#vs Pronamel Daily Protection

ALWAYS FOLLOW THE LABEL

Trademarks owned or licensed by GSK. ©2022 GSK or licensor.

Distributed by: GSK Consumer Healthcare,Warren, NJ 07059

Principal Display Panel

SENSODYNE

PRONAMEL ACTIVE SHIELD

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

FRESH MINT

Builds Enamel Resistance

For Cavity & Erosion Protection

NET WT 3.4 OZ (96.4 g)

62000000200006 – Front Carton

Sensodyne Pronamel Active Shield FM 3.4oz_Carton

Principal Display Panel

SENSODYNE

PRONAMEL

ACTIVE SHIELD

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

COOL MINT WHITENING

Builds Enamel Resistance

For Cavity & Erosion Protection

NET WT 3.4 OZ (96.4 g)

620000000200004 – Front Carton

Sensodyne Pronamel Active Shield CM 3.4oz_Carton
SENSODYNE PRONAMEL   ACTIVE SHIELD FRESH MINT
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0700
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)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Fresh Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0700-011 in 1 CARTON01/02/2023
196.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0700-0223 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 DrugM02201/02/2023
SENSODYNE PRONAMEL   ACTIVE SHIELD COOL MINT
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0135-0701
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)  
XANTHAN GUM (UNII: TTV12P4NEE)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Product Characteristics
Color    Score    
ShapeSize
FlavorMINT (Cool Mint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0135-0701-011 in 1 CARTON01/02/2023
196.4 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0135-0701-021 in 1 CARTON01/02/2023
265.2 g in 1 TUBE; Type 0: Not a Combination Product
3NDC:0135-0701-032 in 1 CARTON01/02/2024
396.4 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM02201/02/2023
Labeler - Haleon US Holdings LLC (079944263)

Revised: 3/2024
Document Id: 12dd7448-a7e1-9b94-e063-6394a90a6d48
Set id: e8684615-f544-4871-b935-0a0f93639d7d
Version: 4
Effective Time: 20240304
 
Haleon US Holdings LLC