drug facts

drug facts
SPL v3
SPL
SPL Set ID 99037e59-53d6-492c-8fce-67641fc8efdd
Route
oral
Published
Effective Date 2023-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
nitrate ion (50 mg) fluoride ion (2.5 mg)
Inactive Ingredients
sorbitol hydrated silica glycerin sodium tripolyphosphate anhydrous polyethylene glycol 400 sodium lauryl sulfate aluminum oxide titanium dioxide xanthan gum cocamidopropyl betaine soda lime carrageenan saccharin sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2024-01-02

Purpose

Antihypersensitivity Anticavity

Description

Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)


Medication Information

Warnings

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

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)
Inactive Ingredients

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, flavor, alumina, titanium dioxide, xanthan gum, cocamidopropyl betaine, sodium hydroxide, carrageenan, sodium saccharin

Description

Potassium nitrate 5% Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Purposes

Antihypersensitivity

Anticavity

Active Ingredients

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Questions Or Comments?

1-866-844-2797

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 (stain Protector)

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINICAL

WHITE

CLINICAL PROVEN

WHITENING

DESIGNED FOR

SENSITIVE TEETH

WHITENING

Clinically proven whitening ingredients remove stains, polish teeth and help prevent future stains

SENSITIVITY PROTECTION

Clinically proven ingredients to protect against sensitivity and strengthen enamel

Helps protect teeth from future stains

ENAMEL SAFE

* As shown in an 8 week study.

** With twice daily brushing.

Distributed by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

© 2023 Haleon or licensor.

Principal Display Panel (stain Protector)

NEW

#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

2 SHADES WHITER TEETH*

+24/7 SENSITIVITY PROTECTION**

CLINICAL

WHITE

STAIN PROTECTOR

NET WT 3.4 OZ (96.4 g)

Additional Information (enamel Strengthening)

ALWAYS FOLLOW THE LABEL

SENSODYNE CLINICAL WHITE

CLINICALLY PROVEN WHITENINGDESIGNED FOR SENSITIVE TEETH

WHITENING

Clinically proven whitening ingredients remove stains, polish teeth and help prevent future stains

SENSITIVITY PROTECTION

Clinically proven ingredients to protect against sensitivity and strengthen enamel.

Strengthens enamel

ENAMEL SAFE

* As shown in an 8 week study.

** With twice daily brushing.

Principal Display Panel (enamel Strengthening)

HALEON

TOOTHPASE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNE

2 SHADES WHITER TEETH*

+24/7 SENSITIVITY PROTECTION**

CLINICAL

WHITE

#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

ENAMEL STRENGTHENING

NET WT 5.5 OZ (156 g)


Structured Label Content

Warnings

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

water, sorbitol, hydrated silica, glycerin, pentasodium triphosphate, PEG-8, sodium lauryl sulfate, flavor, alumina, titanium dioxide, xanthan gum, cocamidopropyl betaine, sodium hydroxide, carrageenan, sodium saccharin

Purposes

Antihypersensitivity

Anticavity

Active Ingredients (Active ingredients)

Potassium nitrate 5%

Sodium fluoride 0.25% (0.15% w/v fluoride ion)

Questions Or Comments? (Questions or comments?)

1-866-844-2797

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 (stain Protector) (Additional Information (Stain Protector))

ALWAYS FOLLOW THE LABEL

SENSODYNE

CLINICAL

WHITE

CLINICAL PROVEN

WHITENING

DESIGNED FOR

SENSITIVE TEETH

WHITENING

Clinically proven whitening ingredients remove stains, polish teeth and help prevent future stains

SENSITIVITY PROTECTION

Clinically proven ingredients to protect against sensitivity and strengthen enamel

Helps protect teeth from future stains

ENAMEL SAFE

* As shown in an 8 week study.

** With twice daily brushing.

Distributed by: Haleon, Warren, NJ 07059

Trademarks owned or licensed by Haleon.

© 2023 Haleon or licensor.

Principal Display Panel (stain Protector) (Principal Display Panel (Stain Protector))

NEW

#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

SENSODYNE

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

2 SHADES WHITER TEETH*

+24/7 SENSITIVITY PROTECTION**

CLINICAL

WHITE

STAIN PROTECTOR

NET WT 3.4 OZ (96.4 g)

Additional Information (enamel Strengthening) (Additional Information (Enamel Strengthening))

ALWAYS FOLLOW THE LABEL

SENSODYNE CLINICAL WHITE

CLINICALLY PROVEN WHITENINGDESIGNED FOR SENSITIVE TEETH

WHITENING

Clinically proven whitening ingredients remove stains, polish teeth and help prevent future stains

SENSITIVITY PROTECTION

Clinically proven ingredients to protect against sensitivity and strengthen enamel.

Strengthens enamel

ENAMEL SAFE

* As shown in an 8 week study.

** With twice daily brushing.

Principal Display Panel (enamel Strengthening) (Principal Display Panel (Enamel Strengthening))

HALEON

TOOTHPASE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNE

2 SHADES WHITER TEETH*

+24/7 SENSITIVITY PROTECTION**

CLINICAL

WHITE

#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

ENAMEL STRENGTHENING

NET WT 5.5 OZ (156 g)


Advanced Ingredient Data


Raw Label Data

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