Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 2d433ac1-3ddf-a2f4-e063-6394a90a91f8
Route
ORAL
Published
Effective Date 2025-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (15 mg)
Inactive Ingredients
Glycerin Polyethylene Glycol 400 Hydrated Silica Sodium Tripolyphosphate Anhydrous Perlite Sodium Lauryl Sulfate Silicon Dioxide Polyacrylic Acid (250000 Mw) Cocamidopropyl Betaine Saccharin Sodium Basic Blue 1

Identifiers & Packaging

Pill Appearance
Color: blue
Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-12-01

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)
Inactive Ingredients

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, perlite, flavor, sodium lauryl sulfate, silica, polyacrylic acid, cocamidopropyl betaine, sodium saccharin, blue 1

Questions Or Comments?

1-866-844-2797

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 (fresh Clean)

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINCAL REPAIR

CLINICALLY PROVEN

SENSITIVITY RELIEF

ACTIVATES

Formula activates as soon as you begin to brush your teeth*

REPAIRS

Forms a protective layer inside and over exposed sensitive areas** to block the nerves from sensitivity triggers

PROTECTS

Clinically proven to provide long-lasting sensitivity relief and help prevent the pain from coming back**

SUPERIOR CLEANING ACTION

through stain removal***

Gentle on sensitive teeth

*for substantial sensitivity relief in 3 days

**with continued twice daily brushing

***vs Sensodyne Repair & Protect Deep Repair

Principal Display Panel Fresh Clean

NEW

HALEON

TOOTHPASTE FOR SENSTIVE TEETH AND CAVITY PREVENTION

SENSODYNE

STARTS TO REPAIR SENSTIVE AREAS OF TEETH AFTER 60 SEC*

CLINICAL REPAIR

REPARATIVE ACTION PROVEN TO RELIEVE SENSITIVITY

FRESH CLEAN

NET WT 3.4 OZ (96.4 g)

Additional Information (whiten & Shine)

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINICAL REPAIR

CLINCALLY PROVEN

SENSITIVITY RELIEF

ACTIVATES

Formula activates as soon as you begin to brush your teeth*

REPAIRS

Forms a protective layer inside and over exposed sensitive areas** to block the nerves from sensitivity triggers

PROTECTS

Clinically proven to provide long-lasting sensitivity relief and help prevent the pain from coming back**

SUPERIOR WHITENING ACTION

through stain removal***

Gentle on sensitive teeth

*for substantial sensitivity relief in 3 days

**with continued twice daily brushing

***vs Sensodyne Repair & Protect Deep Repair

Principal Display Panel Whiten & Shine

NEW

HALEON

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNE

STARTS TO REPAIR SENSITIVE AREAS OF THE TEETH AFTER 60 SEC*

CLINICAL REPAIR

REPARATIVE ACTION PROVEN TO RELIEVE SENSITIVITY

WHITEN & SHINE

NET WT 3.4 OZ (96.4 g)


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)
Inactive Ingredients (Inactive ingredients)

glycerin, PEG-8, hydrated silica, pentasodium triphosphate, perlite, flavor, sodium lauryl sulfate, silica, polyacrylic acid, cocamidopropyl betaine, sodium saccharin, blue 1

Questions Or Comments? (Questions or comments?)

1-866-844-2797

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 (fresh Clean) (Additional Information (Fresh Clean))

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINCAL REPAIR

CLINICALLY PROVEN

SENSITIVITY RELIEF

ACTIVATES

Formula activates as soon as you begin to brush your teeth*

REPAIRS

Forms a protective layer inside and over exposed sensitive areas** to block the nerves from sensitivity triggers

PROTECTS

Clinically proven to provide long-lasting sensitivity relief and help prevent the pain from coming back**

SUPERIOR CLEANING ACTION

through stain removal***

Gentle on sensitive teeth

*for substantial sensitivity relief in 3 days

**with continued twice daily brushing

***vs Sensodyne Repair & Protect Deep Repair

Principal Display Panel Fresh Clean (Principal Display Panel- Fresh Clean)

NEW

HALEON

TOOTHPASTE FOR SENSTIVE TEETH AND CAVITY PREVENTION

SENSODYNE

STARTS TO REPAIR SENSTIVE AREAS OF TEETH AFTER 60 SEC*

CLINICAL REPAIR

REPARATIVE ACTION PROVEN TO RELIEVE SENSITIVITY

FRESH CLEAN

NET WT 3.4 OZ (96.4 g)

Additional Information (whiten & Shine) (Additional Information (Whiten & Shine))

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINICAL REPAIR

CLINCALLY PROVEN

SENSITIVITY RELIEF

ACTIVATES

Formula activates as soon as you begin to brush your teeth*

REPAIRS

Forms a protective layer inside and over exposed sensitive areas** to block the nerves from sensitivity triggers

PROTECTS

Clinically proven to provide long-lasting sensitivity relief and help prevent the pain from coming back**

SUPERIOR WHITENING ACTION

through stain removal***

Gentle on sensitive teeth

*for substantial sensitivity relief in 3 days

**with continued twice daily brushing

***vs Sensodyne Repair & Protect Deep Repair

Principal Display Panel Whiten & Shine (Principal Display Panel- Whiten & Shine)

NEW

HALEON

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNE

STARTS TO REPAIR SENSITIVE AREAS OF THE TEETH AFTER 60 SEC*

CLINICAL REPAIR

REPARATIVE ACTION PROVEN TO RELIEVE SENSITIVITY

WHITEN & SHINE

NET WT 3.4 OZ (96.4 g)


Advanced Ingredient Data


Raw Label Data

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