Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID e8684615-f544-4871-b935-0a0f93639d7d
Route
ORAL
Published
Effective Date 2022-08-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.15 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Polyethylene Glycol 400 Sodium Lactate Xanthan Gum Cocamidopropyl Betaine Sodium Methyl Cocoyl Taurate Titanium Dioxide Saccharin Sodium Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-02

Description

Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Purpose

Antihypersensitivity Anticavity


Medication Information

Purpose

Antihypersensitivity Anticavity

Description

Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Uses
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • aids in the prevention of dental cavities.
Purposes

Antihypersensitivity

Anticavity

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.
Active Ingredient

Potassium nitrate 5%

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

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

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

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.

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

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


Structured Label Content

Uses
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
  • aids in the prevention of dental cavities.
Purposes

Antihypersensitivity

Anticavity

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.
Active Ingredient (Active ingredient)

Potassium nitrate 5%

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

Other Information (Other information)
  • do not store above 25°C (77°F)
Inactive Ingredients (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? (Questions or comments?)

1-866-844-2797

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

Stop Use and Ask A Dentist If (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. (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.

Additional Information (cool Mint) (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

Additional Information (fresh Mint) (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


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