Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID c977f2c4-e0f3-44d2-aa7a-845f0583af3e
Route
DENTAL
Published
Effective Date 2022-11-09
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 Cocamidopropyl Betaine Sodium Methyl Cocoyl Taurate Titanium Dioxide Xanthan Gum Sodium Hydroxide Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-04-03

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 25°C (77°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, cocamidopropyl betaine, sodium methyl cocoyl taurate, titanium dioxide, xanthan gum, sodium hydroxide, sodium saccharin

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 daily brushing.

Exposed Dentin

24/7

Sensitivity Protection*

+ Strong & Healthy Teeth

Use Sensodyne Extra Whitening

Cool Mint twice dally:

• Long lasting sensitivity protection* everyday

• Contains fluoride to protect against cavities

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

©2022 GSK group of companies or its licensor.

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

Questions Or Comments?

1-866-844-2797

Principal Display Panel

SENSODYNE

#1 DENTIST RECOMMENDED BRAND

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

Extra Whitening

Cool Mint

NET WT 4.0 OZ (113 g)

62000000079742 Front Carton

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.

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.

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 25°C (77°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, cocamidopropyl betaine, sodium methyl cocoyl taurate, titanium dioxide, xanthan gum, sodium hydroxide, sodium saccharin

Additional Information (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 daily brushing.

Exposed Dentin

24/7

Sensitivity Protection*

+ Strong & Healthy Teeth

Use Sensodyne Extra Whitening

Cool Mint twice dally:

• Long lasting sensitivity protection* everyday

• Contains fluoride to protect against cavities

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

©2022 GSK group of companies or its licensor.

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

SENSODYNE

#1 DENTIST RECOMMENDED BRAND

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

Extra Whitening

Cool Mint

NET WT 4.0 OZ (113 g)

62000000079742 Front Carton

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.

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.

Advanced Ingredient Data


Raw Label Data

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