Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 34a1a32e-3017-f018-e063-6394a90a0230
Route
DENTAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.5 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Polyethylene Glycol 400 Sodium Lactate Cocamidopropyl Betaine Xanthan Gum Silicon Dioxide Titanium Dioxide Saccharin Sodium Methyl Vinyl Ether And Maleic Acid Copolymer (1750000 Wamw) Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

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) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing.
  • 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, xanthan gum, silica, titanium dioxide, sodium saccharin, PVM/MA copolymer, sodium hydroxide

Additional Information

ALWAYS FOLOW THE LABEL

SENSODYNE PRONAMEL CLINICAL ENAMEL STRENGTH

CLINICALLY PROVEN ENAMEL STRENGTHENING

REPAIRS

66%of enamel microdamage in the most vulnerable areas of your teeth^

24/7 PROTECTION

against early stage cavities, sensitivity and future enamel damage**

To help protect teeth for life**

LEAVES YOUR MOUTH

feeling clean and fresh

FRESH MINT

*Vs. your mouth’s natural defenses.

**With twice daily brushing.

^Acid weakened enamel. On average as shown in 7 day lab test.

Questions Or Comments?

1-866-844-2797

Principal Display Panel

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PROTECTION

SENSODYNE PRONAMEL

3x STRONGER ENAMEL PROTECTION*

CLINICAL ENAMEL STRENGTH

#1 DENTIST RECOMMENDED BRAND FOR ENAMEL EROSION

FRESH BREATH

NET WT 3.4 OZ (96.4 g)

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) or as recommended by a dentist or doctor. Make sure to brush all sensitive areas of the teeth. Minimize swallowing.
  • 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, xanthan gum, silica, titanium dioxide, sodium saccharin, PVM/MA copolymer, sodium hydroxide

Additional Information

ALWAYS FOLOW THE LABEL

SENSODYNE PRONAMEL CLINICAL ENAMEL STRENGTH

CLINICALLY PROVEN ENAMEL STRENGTHENING

REPAIRS

66%of enamel microdamage in the most vulnerable areas of your teeth^

24/7 PROTECTION

against early stage cavities, sensitivity and future enamel damage**

To help protect teeth for life**

LEAVES YOUR MOUTH

feeling clean and fresh

FRESH MINT

*Vs. your mouth’s natural defenses.

**With twice daily brushing.

^Acid weakened enamel. On average as shown in 7 day lab test.

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PROTECTION

SENSODYNE PRONAMEL

3x STRONGER ENAMEL PROTECTION*

CLINICAL ENAMEL STRENGTH

#1 DENTIST RECOMMENDED BRAND FOR ENAMEL EROSION

FRESH BREATH

NET WT 3.4 OZ (96.4 g)

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)