Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f757ccdd-b316-4799-a34a-10edbb73da6b
Route
ORAL
Published
Effective Date 2024-07-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.11 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Sodium Tripolyphosphate Anhydrous Polyethylene Glycol 400 Xanthan Gum Sodium Methyl Cocoyl Taurate Cocamidopropyl Betaine Titanium Dioxide Sodium Hydroxide Saccharin Sodium Sucralose

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-12

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 of age: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, pentasodium triphosphate, PEG-8, flavor, silica, xanthan gum, sodium methyl cocoyl taurate, cocamidopropyl betaine, titanium dioxide, sodium hydroxide, sodium saccharin, sucralose

Additional Information

SENSODYNE

Advanced Whitening PLUS

What are sensitive teeth?

Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or

drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity,

for example, with cold and hot food and drinks.

What does Sensodyne do?

Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness.

helps remove stains for a whiter smile, while calming the nerves deep inside the tooth for 24 hour sensitivity relief*that helps keep the pain from coming back

24/7 Sensitivity Protection*

+ Triple Action Whitening

Use Sensodyne Advanced Whitening PLUS twice daily:

• Long lasting sensitivity protection*

+ Triple action whitening

  • Removes stains
  • Polishes enamel
  • Prevents future stains

• Contains fluoride to protect against cavities

* with twice daily brushing

^ removes stains, polishes enamel,

and prevents future stains

† lower abrasivity vs Sensodyne

Advanced Whitening

CARTON RECYCLE

TUBE RECYCLE

CAP CHECK LOCALLY

†Recycling facilities for the cap may not exist in your area

Save Water

Turn off tap while brushing

Recyclable Packaging

Recyclable Carton

Recyclable Tube & Cap

Distributed by:

Haleon

Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2024 Haleon or licensor.

Pat. Info www.productpats.com

62000000209613

Questions Or Comments?

1-866-844-2797

ALWAYS FOLLOW THE LABEL

Principal Display Panel

4 Pack HALEON

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

Advanced Whitening PLUS

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

24/7 SENSITIVITY PROTECTION + TRIPLE ACTION WHITENING

4 TUBES OF 6.5 OZ (184 g) EACH - TOTAL NET WT 26 OZ (736 g)

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 of age: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, pentasodium triphosphate, PEG-8, flavor, silica, xanthan gum, sodium methyl cocoyl taurate, cocamidopropyl betaine, titanium dioxide, sodium hydroxide, sodium saccharin, sucralose

Additional Information (Additional information)

SENSODYNE

Advanced Whitening PLUS

What are sensitive teeth?

Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or

drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity,

for example, with cold and hot food and drinks.

What does Sensodyne do?

Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily fluoride toothpaste - strong teeth and freshness.

helps remove stains for a whiter smile, while calming the nerves deep inside the tooth for 24 hour sensitivity relief*that helps keep the pain from coming back

24/7 Sensitivity Protection*

+ Triple Action Whitening

Use Sensodyne Advanced Whitening PLUS twice daily:

• Long lasting sensitivity protection*

+ Triple action whitening

  • Removes stains
  • Polishes enamel
  • Prevents future stains

• Contains fluoride to protect against cavities

* with twice daily brushing

^ removes stains, polishes enamel,

and prevents future stains

† lower abrasivity vs Sensodyne

Advanced Whitening

CARTON RECYCLE

TUBE RECYCLE

CAP CHECK LOCALLY

†Recycling facilities for the cap may not exist in your area

Save Water

Turn off tap while brushing

Recyclable Packaging

Recyclable Carton

Recyclable Tube & Cap

Distributed by:

Haleon

Warren, NJ 07059

Trademarks owned or licensed by Haleon.

©2024 Haleon or licensor.

Pat. Info www.productpats.com

62000000209613

Questions Or Comments? (Questions or comments?)

1-866-844-2797

ALWAYS FOLLOW THE LABEL

Principal Display Panel

4 Pack HALEON

#1 DENTIST RECOMMENDED BRAND

SENSODYNE

Advanced Whitening PLUS

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

24/7 Sensitivity Protection* + Strong & Healthy Teeth

24/7 SENSITIVITY PROTECTION + TRIPLE ACTION WHITENING

4 TUBES OF 6.5 OZ (184 g) EACH - TOTAL NET WT 26 OZ (736 g)

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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