Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID a2f9d58b-671b-4427-a971-1fceff5f2323
Route
ORAL
Published
Effective Date 2023-07-27
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 Cocamidopropyl Betaine Titanium Dioxide Xanthan Gum Saccharin Sodium Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-01-06

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.
Other Information
  • do not store above 25°C (77°F)
Active Ingredients

Potassium nitrate 5%

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

Inactive Ingredients

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?

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

Repairs Weakened Enamel*

For Strong, Healthy Teeth

NET WT 3.4 OZ (96.4 g)

SENSODYNE PRONAMEL

INTENSIVE ENAMEL REPAIR

* Sensodyne Pronamel Intensive Enamel Repairis proven to drive minerals deepinto the enamel surface to help actively repairacid-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.

Recycle Carton, Tube and Cap

Save Water Turn off tap while brushing

ALWAYS FOLLOW THE LABEL

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

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

62000000069608 Front Carton

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.


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.
Other Information (Other information)
  • do not store above 25°C (77°F)
Active Ingredients (Active ingredients)

Potassium nitrate 5%

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

Inactive Ingredients (Inactive ingredients)

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? (Questions or comments?)

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

Repairs Weakened Enamel*

For Strong, Healthy Teeth

NET WT 3.4 OZ (96.4 g)

SENSODYNE PRONAMEL

INTENSIVE ENAMEL REPAIR

* Sensodyne Pronamel Intensive Enamel Repairis proven to drive minerals deepinto the enamel surface to help actively repairacid-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.

Recycle Carton, Tube and Cap

Save Water Turn off tap while brushing

ALWAYS FOLLOW THE LABEL

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

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

62000000069608 Front Carton

When Using This Product, (When using this product,)

if irritation occurs discontinue use.

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.


Advanced Ingredient Data


Raw Label Data

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