SENSODYNE PRONAMEL ACTIVE SHIELD FRESH MINT- potassium nitrate and sodium fluoride paste SENSODYNE PRONAMEL ACTIVE SHIELD COOL MINT- potassium nitrate and sodium fluoride paste

SENSODYNE PRONAMEL by

Drug Labeling and Warnings

SENSODYNE PRONAMEL by is a Otc medication manufactured, distributed, or labeled by GlaxoSmithKline Consumer Healthcare Holdings (US). Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Potassium nitrate 5%

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

Purposes

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

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

• do not store above 25°C (77°F)

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

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

INGREDIENTS AND APPEARANCE

SENSODYNE PRONAMEL   ACTIVE SHIELD FRESH MINT
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0700
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)
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
Shape		Size
Flavor	MINT (Fresh Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0700-01	1 in 1 CARTON	01/02/2023
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0700-02	23 g in 1 TUBE; Type 0: Not a Combination Product	01/02/2023

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M022	01/02/2023

SENSODYNE PRONAMEL   ACTIVE SHIELD COOL MINT
potassium nitrate and sodium fluoride paste

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0135-0701
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)
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
Shape		Size
Flavor	MINT (Cool Mint)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0135-0701-01	1 in 1 CARTON	01/02/2023
1		96.4 g in 1 TUBE; Type 0: Not a Combination Product
2	NDC: 0135-0701-02	1 in 1 CARTON	01/02/2023
2		65.2 g in 1 TUBE; Type 0: Not a Combination Product
3	NDC: 0135-0701-03	2 in 1 CARTON	01/02/2024
3		96.4 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	01/02/2023

Labeler - Haleon US Holdings LLC (079944263)