Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID 671f8f45-389c-4375-be43-f5500ee21a0e
Route
DENTAL
Published
Effective Date 2024-03-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Nitrate Ion (50 mg) Fluoride Ion (1.15 mg)
Inactive Ingredients
Sorbitol Water Glycerin Hydrated Silica Sodium Tripolyphosphate Anhydrous Polyethylene Glycol 400 Titanium Dioxide Sodium Methyl Cocoyl Taurate Cocamidopropyl Betaine Xanthan Gum Sodium Hydroxide Saccharin Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-12-21

Description

Potassium nitrate 5%** Sodium fluoride 0.25% (0.16% w/v fluoride ion)

Purpose

Antihypersensitivity Anticavity


Medication Information

Purpose

Antihypersensitivity

Anticavity

Description

Potassium nitrate 5%** Sodium fluoride 0.25% (0.16% 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.
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:Consult a dentist or doctor.
Other Information
  • store below 30°C (86°F)
Active Ingredients

Potassium nitrate 5%**

Sodium fluoride 0.25% (0.16% w/v fluoride ion)

Inactive Ingredients

sorbitol, water, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin

Questions Or Comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC 0135-0581-01

SENSODYNE ®

TRUE

white ®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

MINT

Sensitivity Relief*

Stain Prevention • Stain Removal

CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF*

No. 1 DENTIST RECOMMENDED BRAND

FOR SENSITIVE TEETH

NET WT 3.0 OZ (85 g)

Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne ® True White ® has the lowest abrasion formulation ever in a Sensodyne ® toothpaste.

With twice daily brushing it:

  • is proven to relieve sensitivity pain
  • helps to gently whiten your teeth
  • leaves a protective shield to help prevent new stains forming
  • freshens breath, fights cavities and helps keep gums healthy

*with twice daily brushing

**maximum FDA sensitivity active ingredient

GSKConsumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2015 GSK group of companies or its licensor. All rights reserved

ALWAYS FOLLOW THE LABEL

105639XA

When Using This Product,

if irritation occurs discontinue use.

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.
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:Consult a dentist or doctor.
Other Information (Other information)
  • store below 30°C (86°F)
Active Ingredients (Active ingredients)

Potassium nitrate 5%**

Sodium fluoride 0.25% (0.16% w/v fluoride ion)

Inactive Ingredients (Inactive ingredients)

sorbitol, water, glycerin, hydrated silica, pentasodium triphosphate, PEG-8, flavor, titanium dioxide, sodium methyl cocoyl taurate, cocamidopropyl betaine, xanthan gum, sodium hydroxide, sodium saccharin

Questions Or Comments? (Questions or comments?)

Call toll-free 1-866-844-2797

Principal Display Panel

NDC 0135-0581-01

SENSODYNE ®

TRUE

white ®

TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION

MINT

Sensitivity Relief*

Stain Prevention • Stain Removal

CLINICALLY PROVEN INGREDIENT FOR SENSITIVITY RELIEF*

No. 1 DENTIST RECOMMENDED BRAND

FOR SENSITIVE TEETH

NET WT 3.0 OZ (85 g)

Brushing with abrasive toothpaste can wear the sensitive areas of your teeth. Sensodyne ® True White ® has the lowest abrasion formulation ever in a Sensodyne ® toothpaste.

With twice daily brushing it:

  • is proven to relieve sensitivity pain
  • helps to gently whiten your teeth
  • leaves a protective shield to help prevent new stains forming
  • freshens breath, fights cavities and helps keep gums healthy

*with twice daily brushing

**maximum FDA sensitivity active ingredient

GSKConsumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

©2015 GSK group of companies or its licensor. All rights reserved

ALWAYS FOLLOW THE LABEL

105639XA

When Using This Product, (When using this product,)

if irritation occurs discontinue use.

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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