Drug Facts

Drug Facts
SPL v11
SPL
SPL Set ID f9589e7c-c5ca-4465-8d37-47ad6c69249f
Route
ORAL
Published
Effective Date 2021-12-08
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.1 mg)
Inactive Ingredients
Glycerin Polyethylene Glycol 400 Hydrated Silica Sodium Tripolyphosphate Anhydrous Sodium Lauryl Sulfate Titanium Dioxide Cocamidopropyl Betaine Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-07-08

Description

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Purpose

Anticavity Antihypersensitivity


Medication Information

Purpose

Anticavity Antihypersensitivity

Description

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Uses
  • aids in the prevention of dental cavities.
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.
Purposes

Anticavity

Antihypersensitivity

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.
Active Ingredient

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Other Information
  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this product is specifically formulated to help prevent staining
  • do not store above 30°C (86°F)
Additional Information

ALWAYS FOLLOW THE LABEL

SENSODYNE RAPIDRELIEF

What is tooth sensitivity?

Sensitivity occurs when the dentin underneath tooth enamel becomes exposed. When exposed dentin comes into contact with hot or cold, sweet or sour, or even your toothbrush, it can trigger the nerve causing a short, sharp pain.

CAUSE OF SENSITIVITY PAIN

TINY HOLES IN DENTIN

FAST ACTING FORMULA

QUICKLY CREATES A BARRIER

FAST RELIEF FROM PAIN*

Fast RELIEF* and Long lasting Protection**

Sensodyne Rapid Relief is clinically proven for fast relief of sensitivity pain.

Its formula quickly creates a barrier over sensitive areas of your teeth to provide fast relief, and to help stop the pain from coming back. With twice daily brushing, it builds ongoing protection from the pain of sensitive teeth. It also helps whiten enamel and prevents staining.

*significant pain relief in 3 days

**with twice daily brushing

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

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

AND CAVITY PREVENTION

EXTRA FRESH

RAPID RELIEF

& LONG LASTING PROTECTION**

NET WT 3.4 OZ (96.4 g)

62000000207034

Inactive Ingredients (mint)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine

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.

Inactive Ingredients (whitening)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine

Inactive Ingredients (extra Fresh)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin


Structured Label Content

Uses
  • aids in the prevention of dental cavities.
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets or contact.
Purposes

Anticavity

Antihypersensitivity

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.
Active Ingredient (Active ingredient)

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Other Information (Other information)
  • products containing stannous fluoride may produce surface staining of the teeth. Adequate toothbrushing may prevent these stains which are not harmful or permanent and may be removed by your dentist.
  • this product is specifically formulated to help prevent staining
  • do not store above 30°C (86°F)
Additional Information

ALWAYS FOLLOW THE LABEL

SENSODYNE RAPIDRELIEF

What is tooth sensitivity?

Sensitivity occurs when the dentin underneath tooth enamel becomes exposed. When exposed dentin comes into contact with hot or cold, sweet or sour, or even your toothbrush, it can trigger the nerve causing a short, sharp pain.

CAUSE OF SENSITIVITY PAIN

TINY HOLES IN DENTIN

FAST ACTING FORMULA

QUICKLY CREATES A BARRIER

FAST RELIEF FROM PAIN*

Fast RELIEF* and Long lasting Protection**

Sensodyne Rapid Relief is clinically proven for fast relief of sensitivity pain.

Its formula quickly creates a barrier over sensitive areas of your teeth to provide fast relief, and to help stop the pain from coming back. With twice daily brushing, it builds ongoing protection from the pain of sensitive teeth. It also helps whiten enamel and prevents staining.

*significant pain relief in 3 days

**with twice daily brushing

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

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH

AND CAVITY PREVENTION

EXTRA FRESH

RAPID RELIEF

& LONG LASTING PROTECTION**

NET WT 3.4 OZ (96.4 g)

62000000207034

Inactive Ingredients (mint) (Inactive ingredients (Mint))

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine

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.

Inactive Ingredients (whitening) (Inactive Ingredients (Whitening))

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine

Inactive Ingredients (extra Fresh) (Inactive ingredients (Extra Fresh))

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin


Advanced Ingredient Data


Raw Label Data

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