Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 3dfa6827-3aae-4f19-93f6-2ded2faf2ddd
Route
DENTAL
Published
Effective Date 2022-11-08
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 Cocamidopropyl Betaine Xanthan Gum Titanium Dioxide Saccharin Sodium Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-03

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, flavor, cocamidopropyl betaine, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

Additional Information

ALWAYS FOLLOW THE LABEL

SENSODYNE PRONAMEL

Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.

ACID ATTACKS ENAMEL

WEAKENING THE ENAMEL STRUCTURE

PRONAMEL REBUILDS & RESTORES ENAMEL

FOR STRONG HEALTHY TEETH

Healthy white teeth start with strong enamel.

Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

With twice-daily brushing, Pronamel helps to:

• Rebuild enamel strength for strong, healthy teeth

• Protect against the effects of dietary acids

• Relieve sensitive teeth

• Freshen breath

• Protect against cavities

Recycle Carton, Tube and Cap

Save Water

Turn off tap while brushing

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2022 GSK group of companies or its licensor.

Questions Or Comments?

1-866-844-2797

Principal Display Panel

SENSODYNE

PRONAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Fresh Mint

GENTLE WHITENING

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

NET WT 4.0 OZ (113 g)

62000000079590 Front Carton

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.

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.

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, flavor, cocamidopropyl betaine, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

Additional Information (Additional information)

ALWAYS FOLLOW THE LABEL

SENSODYNE PRONAMEL

Acidic foods and drinks can cause enamel loss that can lead to yellowing, dullness and sensitivity. Pronamel has a specialty formulation to help rebuild and restore acid weakened enamel, helping prevent enamel loss for strong, healthy teeth.

ACID ATTACKS ENAMEL

WEAKENING THE ENAMEL STRUCTURE

PRONAMEL REBUILDS & RESTORES ENAMEL

FOR STRONG HEALTHY TEETH

Healthy white teeth start with strong enamel.

Pronamel has a proven specialist technology that has been developed to maximize the effect of fluoride on enamel.

With twice-daily brushing, Pronamel helps to:

• Rebuild enamel strength for strong, healthy teeth

• Protect against the effects of dietary acids

• Relieve sensitive teeth

• Freshen breath

• Protect against cavities

Recycle Carton, Tube and Cap

Save Water

Turn off tap while brushing

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2022 GSK group of companies or its licensor.

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

SENSODYNE

PRONAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Fresh Mint

GENTLE WHITENING

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

NET WT 4.0 OZ (113 g)

62000000079590 Front Carton

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.

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.

Advanced Ingredient Data


Raw Label Data

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