Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID f193ec40-032f-42c7-81f1-029ec8989374
Route
ORAL
Published
Effective Date 2024-12-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.1 mg)
Inactive Ingredients
Water Sorbitol Hydrated Silica Glycerin Sodium Tripolyphosphate Anhydrous Peg-8 Monostearate Sodium Lauryl Sulfate Aluminum Oxide Titanium Dioxide Xanthan Gum Cocamidopropyl Betaine Sodium Hydroxide Carrageenan Saccharin Sodium

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-12-31

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 thorough 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.
Generic Section

ALWAYS FOLLOW THE LABEL

SENSODYNE

WHITE

CLINICALLY 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

7X BETTER CLEANING^

Through stain removal

ENAMEL SAFE

* As shown in an 8 week study.

** With twice daily brushing.

^ After 8 weeks twice daily brushing as compared to a non-whitening toothpaste.

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, sodium lauryl sulfate, flavor, alumina, titanium dioxide, xanthan gum, cocamidopropyl betain, sodium hydroxide, carrageenan, sodium saccharin

Questions Or Comments?

1-866-844-2797

Principal Display Panel

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNE

2 SHADES WHITER TEETH*

+ 24/7 SENSITIVITY PROTECTION**

CLINICAL WHITE

#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

INTENSIVE CLEAN

NET WT 3.4 OZ (96.4 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 thorough 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.
Generic Section

ALWAYS FOLLOW THE LABEL

SENSODYNE

WHITE

CLINICALLY 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

7X BETTER CLEANING^

Through stain removal

ENAMEL SAFE

* As shown in an 8 week study.

** With twice daily brushing.

^ After 8 weeks twice daily brushing as compared to a non-whitening toothpaste.

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, sodium lauryl sulfate, flavor, alumina, titanium dioxide, xanthan gum, cocamidopropyl betain, sodium hydroxide, carrageenan, sodium saccharin

Questions Or Comments? (Questions or comments?)

1-866-844-2797

Principal Display Panel

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

SENSODYNE

2 SHADES WHITER TEETH*

+ 24/7 SENSITIVITY PROTECTION**

CLINICAL WHITE

#1 DENTIST RECOMMENDED BRAND FOR SENSITIVE TEETH

INTENSIVE CLEAN

NET WT 3.4 OZ (96.4 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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