Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 5403ab67-532c-4bdf-9b06-07b1866f37f1
Route
DENTAL
Published
Effective Date 2024-03-04
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
Saccharin Sodium Titanium Dioxide Water Sorbitol Hydrated Silica Glycerin Aloe Vera Leaf Coconut Oil Sodium Lauryl Sulfate Xanthan Gum Cocamidopropyl Betaine

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-01-03

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, flavor (contains aloe barbadensis extract and cocos nucifera (coconut) oil), sodium lauryl sulfate, xanthan gum, cocamidopropyl betaine, sodium saccharin, titanium dioxide

Additional Information

ALWAYS FOLLOW THE LABEL

SENSODYNE nourish

WITH BIO-ACTIVE MINERALS

Brush twice daily for a healthier smile:

  • Strengthens & nourishes teeth
  • Helps prevent cavities
  • Protects from sensitivity*
  • Freshens breath

The Sensodyne Nourish rangewith bio-active minerals, strengthens and nourishes teeth while also protecting from sensitivity*. Our toothpaste is designed to provide the everyday nourishment your teeth to help protect the health of your mouth.

Gently Soothing:With trusted sensitivity protection*, our formulation, blended with aloe vera extract and natural mint, is designed for a clean sensation.

*with twice daily brush

Help us support the planet by recycling our packaging and being responsible with water usage.

CARTON

RECYCLE

TUBE

RECYCLE

LOT

See end of carton

Save Water

Turn off tap whilst 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 0135-5026-01

NEW

SENSODYNE

nourish

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NOURISH & STRENGTHEN TEETH FOR A HEALTHY MOUTH

gently soothing

aloe vera & natural mint

WITH BIO-ACTIVE MINERALS

NET WT 4.0 OZ (113 g)

62000000064835 Front Carton

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, flavor (contains aloe barbadensis extract and cocos nucifera (coconut) oil), sodium lauryl sulfate, xanthan gum, cocamidopropyl betaine, sodium saccharin, titanium dioxide

Additional Information

ALWAYS FOLLOW THE LABEL

SENSODYNE nourish

WITH BIO-ACTIVE MINERALS

Brush twice daily for a healthier smile:

  • Strengthens & nourishes teeth
  • Helps prevent cavities
  • Protects from sensitivity*
  • Freshens breath

The Sensodyne Nourish rangewith bio-active minerals, strengthens and nourishes teeth while also protecting from sensitivity*. Our toothpaste is designed to provide the everyday nourishment your teeth to help protect the health of your mouth.

Gently Soothing:With trusted sensitivity protection*, our formulation, blended with aloe vera extract and natural mint, is designed for a clean sensation.

*with twice daily brush

Help us support the planet by recycling our packaging and being responsible with water usage.

CARTON

RECYCLE

TUBE

RECYCLE

LOT

See end of carton

Save Water

Turn off tap whilst 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 0135-5026-01

NEW

SENSODYNE

nourish

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

NOURISH & STRENGTHEN TEETH FOR A HEALTHY MOUTH

gently soothing

aloe vera & natural mint

WITH BIO-ACTIVE MINERALS

NET WT 4.0 OZ (113 g)

62000000064835 Front Carton

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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