Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 911ac7e4-2b92-43d5-af0b-b5f741b088fb
Route
DENTAL
Published
Effective Date 2021-09-23
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 Sorbitol Hydrated Silica Glycerin Activated Charcoal Cocamidopropyl Betaine Xanthan Gum Saccharin Sodium Sodium Hydroxide Sucralose

Identifiers & Packaging

Pill Appearance
Color: black
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-24

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), 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: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, charcoal powder, flavor, cocamidopropyl betaine, xanthan gum, sodium saccharin, sodium hydroxide, sucralose

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.

The active ingredient in Sensodyne is clinically proven to deliver 24/7 sensitivity protection*

Also contains:

Coconut derived charcoal to help restore teeth to their natural whiteness

Use Sensodyne Natural White twice daily:

  • Long-lasting sensitivity protection*
  • Contains fluoride to protect against cavities
  • Helps remove stains for whiter teeth
  • Freshens breath

*with twice daily brushing

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

©2021 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

NDC 0135-5028-01

new

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

Natural White

with coconut derived charcoal

NET WT 4.0 OZ (113 g)

1001361 Carton Front

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: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, charcoal powder, flavor, cocamidopropyl betaine, xanthan gum, sodium saccharin, sodium hydroxide, sucralose

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.

The active ingredient in Sensodyne is clinically proven to deliver 24/7 sensitivity protection*

Also contains:

Coconut derived charcoal to help restore teeth to their natural whiteness

Use Sensodyne Natural White twice daily:

  • Long-lasting sensitivity protection*
  • Contains fluoride to protect against cavities
  • Helps remove stains for whiter teeth
  • Freshens breath

*with twice daily brushing

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

©2021 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

NDC 0135-5028-01

new

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

Natural White

with coconut derived charcoal

NET WT 4.0 OZ (113 g)

1001361 Carton Front

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

All Sections (JSON)