Drug Facts

Drug Facts
SPL v21
SPL
SPL Set ID edffce4d-108b-4ffd-9adf-e12cb42ffddd
Route
ORAL
Published
Effective Date 2024-01-24
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 Titanium Dioxide Xanthan Gum Saccharin Sodium Sodium Hydroxide Mica

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-12-09

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.
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 Ingredients

Potassium nitrate 5%

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

Questions Or Comments?

1-866-844-2797

Principal Display Panel

NDC 0135-0484-01

SENSODYNE

PRONAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Alpine Breeze

GENTLE WHITENING

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

NET WT 4.0 OZ (113g)

ALWAYS FOLLOW THE LABEL

SENSODYNE PRONAMEL

Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

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

†Recycling facilities for this product may not exist in your area

Distributed by:

GSKConsumer Healthcare

Warren, NJ 07059

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

©2021 GSK group of companies or its licensor.

62000000068970 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.

Inactive Ingredients (fresh Breath)

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide

Inactive Ingredients (multi Action)

water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, sodium saccharin, mica, titanium dioxide, sodium hydroxide

Inactive Ingredients (daily Protection)

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide

Inactive Ingredients (gentle Whitening)

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Other Information (gentle Whitening, Daily Protection, Fresh Breath, Multi Action)
  • do not store above 30°C (86°F)

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.
Purpose

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 Ingredients (Active ingredients)

Potassium nitrate 5%

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

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

NDC 0135-0484-01

SENSODYNE

PRONAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Alpine Breeze

GENTLE WHITENING

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

NET WT 4.0 OZ (113g)

ALWAYS FOLLOW THE LABEL

SENSODYNE PRONAMEL

Does not contain: SLS/sulfates • artificial dyes • parabens • triclosan • peroxide

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

†Recycling facilities for this product may not exist in your area

Distributed by:

GSKConsumer Healthcare

Warren, NJ 07059

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

©2021 GSK group of companies or its licensor.

62000000068970 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.

Inactive Ingredients (fresh Breath) (Inactive ingredients (Fresh Breath))

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide

Inactive Ingredients (multi Action) (Inactive ingredients (Multi-Action))

water, sorbitol, hydrated silica, glycerin, flavor, cocamidopropyl betaine, xanthan gum, sodium saccharin, mica, titanium dioxide, sodium hydroxide

Inactive Ingredients (daily Protection) (Inactive ingredients (Daily Protection))

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, xanthan gum, sodium saccharin, titanium dioxide, sodium hydroxide

Inactive Ingredients (gentle Whitening) (Inactive ingredients (Gentle Whitening))

water, sorbitol, hydrated silica, glycerin, PEG-8, cocamidopropyl betaine, flavor, titanium dioxide, xanthan gum, sodium saccharin, sodium hydroxide

Other Information (gentle Whitening, Daily Protection, Fresh Breath, Multi Action) (Other information (Gentle Whitening, Daily Protection, Fresh Breath, Multi-Action))
  • do not store above 30°C (86°F)

Advanced Ingredient Data


Raw Label Data

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