Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID 9e8e7b9f-3ccd-4935-b886-93f3a5045b67
Route
DENTAL
Published
Effective Date 2022-03-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.1 mg)
Inactive Ingredients
Water Hydrated Silica Sorbitol Glycerin Sodium Tripolyphosphate Anhydrous Polyethylene Glycol 400 Titanium Dioxide Cocamidopropyl Betaine Sodium Methyl Cocoyl Taurate Xanthan Gum Sodium Hydroxide Saccharin Sodium Sucralose

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2002-01-02 Until 2021-10-29

Description

Potassium nitrate 5% Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Purpose

Antihypersensitivity Anticavity


Medication Information

Purpose

Antihypersensitivity Anticavity

Description

Potassium nitrate 5% Sodium fluoride 0.24% (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 30°C (86°F)
Active Ingredients

Potassium nitrate 5%

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin, sucralose

Questions Or Comments?

1-866-844-2797

Principal Display Panel

#1 DENTIST RECOMMENDED BRAND HALEON

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth

Full Protection + Whitening

with triple action cleaning formula

NET WT 4.0 OZ (113 g)

62000000208034

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.

Additional Information (tartar Control)

Use Sensodyne Tartar Control

+ Whitening twice daily:

  • Long lasting sensitivity protection* every day
  • Contains fluoride to protect against cavities
Additional Information (full Protection)

ALWAYS FOLLOW THE LABEL

What are sensitive teeth?

Lots of people hove 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 daily brushing.

Exposed Dentin

24/7 Sensitivity Protection*

+ Strong & Healthy Teeth

Use Sensodyne Full Protection

+ Whitening twice daily:

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

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

©2020 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059


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 30°C (86°F)
Active Ingredients (Active ingredients)

Potassium nitrate 5%

Sodium fluoride 0.24% (0.15% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin, sucralose

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

#1 DENTIST RECOMMENDED BRAND HALEON

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 SENSITIVITY PROTECTION* + Strong & Healthy Teeth

Full Protection + Whitening

with triple action cleaning formula

NET WT 4.0 OZ (113 g)

62000000208034

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.

Additional Information (tartar Control) (Additional Information (Tartar Control))

Use Sensodyne Tartar Control

+ Whitening twice daily:

  • Long lasting sensitivity protection* every day
  • Contains fluoride to protect against cavities
Additional Information (full Protection) (Additional Information (Full Protection))

ALWAYS FOLLOW THE LABEL

What are sensitive teeth?

Lots of people hove 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 daily brushing.

Exposed Dentin

24/7 Sensitivity Protection*

+ Strong & Healthy Teeth

Use Sensodyne Full Protection

+ Whitening twice daily:

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

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

©2020 GSK group of companies or its licensor.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059


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Raw Label Data

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