Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 6eb304dd-2a24-4fa0-9d39-71264e88dd16
Route
ORAL
Published
Effective Date 2024-08-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.11 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Cocamidopropyl Betaine Xanthan Gum Titanium Dioxide Saccharin Sodium Sodium Hydroxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-10-01
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, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

Questions Or Comments?

1-866-844-2797

Principal Display Panel

HALEON

4 PACK

SENSODYNE PRONAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

Alpine Breeze

GENTLE WHITENING

ADVANCED PLUS†

2 in 1 WHITENING*

+ STRENGTHENS ENAMEL

4 TUBES OF 6.5 OZ (184 g) EACH – TOTAL NET WT 26 OZ (736 g)

62000000209634 Carton Front

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

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

HALEON

4 PACK

SENSODYNE PRONAMEL

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

Specialist Enamel Protection

Rebuilds, Restores, Refreshes

Alpine Breeze

GENTLE WHITENING

ADVANCED PLUS†

2 in 1 WHITENING*

+ STRENGTHENS ENAMEL

4 TUBES OF 6.5 OZ (184 g) EACH – TOTAL NET WT 26 OZ (736 g)

62000000209634 Carton Front

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

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:03:39.259606 · Updated: 2026-03-14T23:03:49.531028