Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 16225f06-1d40-416a-aaec-7890e398fe4b
Route
DENTAL
Published
Effective Date 2024-05-13
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 Hydrated Silica Sorbitol Glycerin Sodium Tripolyphosphate Anhydrous Polyethylene Glycol 400 Sodium Lauryl Sulfate Xanthan Gum Sodium Hydroxide Cocamidopropyl Betaine Saccharin Sodium Fd&c Blue No. 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-12-19

Description

Potassium nitrate 5% Sodium fluoride 0.25% (0.16% w/v fluoride ion)

Purpose

Antihypersensitivity Anticavity


Medication Information

Purpose

Antihypersensitivity Anticavity

Description

Potassium nitrate 5% Sodium fluoride 0.25% (0.16% 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 30ºC (86ºF)
Active Ingredients

Potassium nitrate 5%

Sodium fluoride 0.25% (0.16% w/v fluoride ion)

Inactive Ingredients

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, sodium hydroxide, cocamidopropyl betaine, sodium saccharin, blue 1

Additional Information

ALWAYS FOLLOW THE LABEL

What are sensitive teeth?

Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity, for example, with cold and hot food and drinks.

What does Sensodyne do?

Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste – strong teeth and freshness.

*with twice dai ly brushing

24/7 Sensitivity Protection*

+ Strong & Healthy Teeth

Exposed Dentin

Use Sensodyne Deep Clean + Whitening twice daily:

  • Long lasting sensitivity protection* every day
  • Contains fluoride to protect against cavities

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

©2023 Haleon group of companies or its licensor.

Distributed by: Haleon, Warren, NJ 07059

Pat. Info www.productpats.com

Questions Or Comments?

1-866-844-2797

Principal Display Panel

#1 DENTIST RECOMMENDED BRAND HALEON

SENSODYNE

Deep Clean + Whitening

with triple action cleaning formula

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

NET WT 4.0 OZ (113 g)

62000000208092

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 30ºC (86ºF)
Active Ingredients (Active ingredients)

Potassium nitrate 5%

Sodium fluoride 0.25% (0.16% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, flavor, xanthan gum, sodium hydroxide, cocamidopropyl betaine, sodium saccharin, blue 1

Additional Information

ALWAYS FOLLOW THE LABEL

What are sensitive teeth?

Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity, for example, with cold and hot food and drinks.

What does Sensodyne do?

Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste – strong teeth and freshness.

*with twice dai ly brushing

24/7 Sensitivity Protection*

+ Strong & Healthy Teeth

Exposed Dentin

Use Sensodyne Deep Clean + Whitening twice daily:

  • Long lasting sensitivity protection* every day
  • Contains fluoride to protect against cavities

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

©2023 Haleon group of companies or its licensor.

Distributed by: Haleon, Warren, NJ 07059

Pat. Info www.productpats.com

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

#1 DENTIST RECOMMENDED BRAND HALEON

SENSODYNE

Deep Clean + Whitening

with triple action cleaning formula

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

NET WT 4.0 OZ (113 g)

62000000208092

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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