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

Purpose

Antihypersensitivity Anticavity

Description

Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)


Medication Information

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), 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)
Inactive Ingredients

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

Description

Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)

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)

Purposes

Antihypersensitivity

Anticavity

Active Ingredients

Potassium nitrate 5%

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

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

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.
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)
Inactive Ingredients (Inactive ingredients)

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

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)

Purposes

Antihypersensitivity

Anticavity

Active Ingredients (Active ingredients)

Potassium nitrate 5%

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

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

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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