Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID d002074b-0580-4247-b3c7-121b8c098697
Route
DENTAL
Published
Effective Date 2025-11-20
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 Cocamidopropyl Betaine Xanthan Gum Titanium Dioxide Saccharin Sodium Sodium Hydroxide

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-15

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

Additional Information

ALWAYS FOLLOW THE LABEL

Specifically formulated to enhance remineralization, which strengthens the tooth’s surface*

Cavities + Sensitivity in teeth are common dental problems

Contains optimized fluoride technology to draw minerals into the tooth structure to help protect against cavities*

*with continued twice daily brushing

Potassium nitrate provides clinically proven long lasting sensitivity protection*

24 HRDUAL PROTECTION FROM CAVITIES & SENSITIVITY* + EVERYDAY FRESHNESS

Questions Or Comments?

1-866-844-2797

Principal Display Panel

new

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection + Strong & Healthy Teeth*

Cavity + Sensitivity 24 HR DUAL PROTECTION*

NET WT 2.7 OZ (77 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, cocamidopropyl betaine, flavor, xanthan gum, titanium dioxide, sodium saccharin, sodium hydroxide

Additional Information

ALWAYS FOLLOW THE LABEL

Specifically formulated to enhance remineralization, which strengthens the tooth’s surface*

Cavities + Sensitivity in teeth are common dental problems

Contains optimized fluoride technology to draw minerals into the tooth structure to help protect against cavities*

*with continued twice daily brushing

Potassium nitrate provides clinically proven long lasting sensitivity protection*

24 HRDUAL PROTECTION FROM CAVITIES & SENSITIVITY* + EVERYDAY FRESHNESS

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

new

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection + Strong & Healthy Teeth*

Cavity + Sensitivity 24 HR DUAL PROTECTION*

NET WT 2.7 OZ (77 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

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