Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID d4e9e5cf-d058-4c3f-ab5e-0b5a20a012e2
Route
ORAL
Published
Effective Date 2024-03-07
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, Unspecified Form Sodium Lauryl Sulfate Titanium Dioxide Cocamidopropyl Betaine Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-01-02

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 control bleeding gums.
  • 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 specially formulated to help prevent staining.
  • do not store above 25°C (77°F)
Inactive Ingredients

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

Additional Information

ALWAYS FOLLOW THE LABEL

SENSODYNE

SENSITIVITY

GUM &

ENAMEL

Gum recession and enamel wear are the two leading causes of sensitive teeth. Gum problems are caused by a build-up of plaque bacteria along the gum line. Enamel wear can be caused by acids in

everyday foods and drinks.

Sensodyne Sensitivity, Gum & Enamelis a daily toothpaste with a clinically proven ingredient to relieve sensitive teeth and improve gum health, while also strengthening the enamel.

1. Builds a protective layer over the sensitive areas

2. Formula with stannous fluoride targets & removes plaque bacteria** in between teeth & gumline.

3. Strengthens enamel surface and protects teeth from acids, while being gentle on enamel.

*with twice daily brushing.

**plaque bacteria associated with gingivitis to help reduce swollen, bleeding gums.

Trademarks owned or licensed by GSK. @2022 GSK or licensor.

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059. Made in Germany

CARTON

RECYCLE

Questions Or Comments?

1-866-844-2797

Principal Display Panel

new

#1 Dentist RecommendED Brand

SENSODYNE

MINT

SENSITIVITY GUM & ENAMEL

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH,

ANTI-GINGIVITIS AND CAVITY PREVENTION

NEW WT 3.4 OZ (96.4 g)

20041 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.
  • 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 maybe signs or symptoms of periodontitis, a serious form of gum disease.
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
  • aids in the prevention of dental cavities.
  • helps control bleeding gums.
  • 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 specially formulated to help prevent staining.
  • do not store above 25°C (77°F)
Inactive Ingredients (Inactive ingredients)

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

Additional Information

ALWAYS FOLLOW THE LABEL

SENSODYNE

SENSITIVITY

GUM &

ENAMEL

Gum recession and enamel wear are the two leading causes of sensitive teeth. Gum problems are caused by a build-up of plaque bacteria along the gum line. Enamel wear can be caused by acids in

everyday foods and drinks.

Sensodyne Sensitivity, Gum & Enamelis a daily toothpaste with a clinically proven ingredient to relieve sensitive teeth and improve gum health, while also strengthening the enamel.

1. Builds a protective layer over the sensitive areas

2. Formula with stannous fluoride targets & removes plaque bacteria** in between teeth & gumline.

3. Strengthens enamel surface and protects teeth from acids, while being gentle on enamel.

*with twice daily brushing.

**plaque bacteria associated with gingivitis to help reduce swollen, bleeding gums.

Trademarks owned or licensed by GSK. @2022 GSK or licensor.

Distributed by: GSK Consumer Healthcare

Warren, NJ 07059. Made in Germany

CARTON

RECYCLE

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

new

#1 Dentist RecommendED Brand

SENSODYNE

MINT

SENSITIVITY GUM & ENAMEL

FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH,

ANTI-GINGIVITIS AND CAVITY PREVENTION

NEW WT 3.4 OZ (96.4 g)

20041 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.
  • 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 maybe signs or symptoms of periodontitis, a serious form of gum disease.
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)