Drug Facts

Drug Facts
SPL v10
SPL
SPL Set ID e3cc3146-8aed-4f6b-a252-e379418c2b8d
Route
DENTAL
Published
Effective Date 2023-12-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Fluoride Ion (1.10 mg)
Inactive Ingredients
Glycerin Polyethylene Glycol 400 Hydrated Silica Sodium Tripolyphosphate Anhydrous Sodium Lauryl Sulfate Titanium Dioxide Polyacrylic Acid (250000 Mw) Saccharin Sodium Cocamidopropyl Betaine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-07-14

Description

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

Purpose

Anticavity, Antigingivitis, Antihypersensitivity


Medication Information

Purpose

Anticavity, Antigingivitis, Antihypersensitivity

Description

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

Uses
  • aids in the prevention of dental cavities.
  • helps prevent gingivitis, an early form of gum disease.
  • helps interfere with harmful effects of plaque associated with gingivitis.
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Purposes

Anticavity, Antigingivitis, 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.
  • store below 30°C (86°F)
Additional Information

SENSODYNE COMPLETE PROTECTION

What is tooth sensitivity?

Sensitivity can be a sign that your teeth are vulnerable, as dentin becomes exposed due to enamel loss or gum recession. When exposed dentin comes into contact with hot or cold, sweet or sour, or even your toothbrush, it can trigger the nerve inside the tooth causing a short, sharp pain.

FRESH FEELING

PROTECTS ENAMEL

HELPS WHITEN ENAMEL

PROTECTS AGAINST PLAQUE

BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS TO SHIELD YOU FROM PAIN*

CLEAN FEELING

HELPS PREVENT GINGIVITIS

*with twice daily brushing

Why use Sensodyne Complete Protection toothpaste?

This formulation has been specifically developed to deliver all the toothpaste benefits your sensitive teeth need. Brush twice a day with Sensodyne Complete Protection toothpaste.

ALWAYS FOLLOW THE LABEL

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

† Recycling facilities for this product may not exist in your area

CARTON RECYCLE

TUBE RECYCLE

CAP CHECK LOCALLY

Questions Or Comments?

1-866-844-2797

Inactive Ingredients (mint)

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

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.

Principal Display Panel (mint)

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH,

ANTIGINGIVITIS AND CAVITY PREVENTION

NET WT 3.4 OZ (96.4 g)

MINT

COMPLETE PROTECTION

SENSITIVITY

ENAMEL

CLEAN

GUMS

FRESH

PLAQUE

WHITENING

62000000207019

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.
  • gingivitis, bleeding, or redness persists for more than 2 weeks.
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Inactive Ingredients (extra Fresh)

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

Principal Display Panel (extra Fresh)

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH,

ANTIGINGIVITIS AND CAVITY PREVENTION

NET WT 3.4 OZ (96.4 g)

EXTRA FRESH

COMPLETE PROTECTION

SENSITIVITY

ENAMEL

CLEAN

GUMS

FRESH

PLAQUE

ENAMEL

WHITENING

62000000207024


Structured Label Content

Uses
  • aids in the prevention of dental cavities.
  • helps prevent gingivitis, an early form of gum disease.
  • helps interfere with harmful effects of plaque associated with gingivitis.
  • builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.
Purposes

Anticavity, Antigingivitis, 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.
  • store below 30°C (86°F)
Additional Information

SENSODYNE COMPLETE PROTECTION

What is tooth sensitivity?

Sensitivity can be a sign that your teeth are vulnerable, as dentin becomes exposed due to enamel loss or gum recession. When exposed dentin comes into contact with hot or cold, sweet or sour, or even your toothbrush, it can trigger the nerve inside the tooth causing a short, sharp pain.

FRESH FEELING

PROTECTS ENAMEL

HELPS WHITEN ENAMEL

PROTECTS AGAINST PLAQUE

BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS TO SHIELD YOU FROM PAIN*

CLEAN FEELING

HELPS PREVENT GINGIVITIS

*with twice daily brushing

Why use Sensodyne Complete Protection toothpaste?

This formulation has been specifically developed to deliver all the toothpaste benefits your sensitive teeth need. Brush twice a day with Sensodyne Complete Protection toothpaste.

ALWAYS FOLLOW THE LABEL

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

† Recycling facilities for this product may not exist in your area

CARTON RECYCLE

TUBE RECYCLE

CAP CHECK LOCALLY

Questions Or Comments? (Questions or comments?)

1-866-844-2797

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

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.

Principal Display Panel (mint) (Principal Display Panel (Mint))

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH,

ANTIGINGIVITIS AND CAVITY PREVENTION

NET WT 3.4 OZ (96.4 g)

MINT

COMPLETE PROTECTION

SENSITIVITY

ENAMEL

CLEAN

GUMS

FRESH

PLAQUE

WHITENING

62000000207019

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.
  • gingivitis, bleeding, or redness persists for more than 2 weeks.
  • you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
Inactive Ingredients (extra Fresh) (Inactive ingredients (Extra Fresh))

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

Principal Display Panel (extra Fresh) (Principal Display Panel (Extra Fresh))

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH,

ANTIGINGIVITIS AND CAVITY PREVENTION

NET WT 3.4 OZ (96.4 g)

EXTRA FRESH

COMPLETE PROTECTION

SENSITIVITY

ENAMEL

CLEAN

GUMS

FRESH

PLAQUE

ENAMEL

WHITENING

62000000207024


Advanced Ingredient Data


Raw Label Data

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