Sensodyne Paste
FDA Label NDC 0135-0621

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Sensodyne (NDC 0135-0621). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredient, purposes, uses, when using this product,, stop use and ask a dentist if, keep out of reach of children., directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Stannous fluoride 0.454% (0.15% w/v fluoride ion)

Purposes

Anticavity, Antihypersensitivity

Uses

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

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.

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

  • 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 specifically formulated to help prevent staining
  • store below 25°C (77°F)

Inactive Ingredients (Extra Fresh)

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

Inactive Ingredients (Mint)

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

Questions Or Comments?

Call toll-free 1-866-844-2797

Principal Display Panel

NDC 0135-0622-01

new

SENSODYNE® Rapid Relief

& Long Lasting Protection**

**with twice daily brushing

FAST RELIEF TOOTHPASTE*

*Significant pain relief in 3 days

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

WITH FLUORIDE

EXTRA FRESH

NET WT 3.4 OZ (96.4 g)

#1 Dentist Recommended Brand┼

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

┼#1 Dentist Recommended Brand for Sensitive Teeth

Fast RELIEF* and Long Lasting Protection**

*significant pain relief in 3 days

Why use Sensodyne Rapid Relief?

Sensodyne Rapid Relief is clinically proven for fast relief of sensitivity pain. Its formula quickly creates a barrier over sensitive areas of your teeth to provide fast relief, and to help stop pain from coming back. With twice daily brushing, it builds ongoing protection from the pain of sensitive teeth. It will leave your mouth feeling clean and fresh, and also helps whiten and prevents staining.

ALWAYS FOLLOW THE LABEL

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

©2016 GSK group of companies or its licensor. All rights reserved.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

106027XA

NDC 0135-0621-01

new

SENSODYNE® Rapid Relief

& Long Lasting Protection**

**with twice daily brushing

FAST RELIEF TOOTHPASTE*

*Significant pain relief in 3 days

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

WITH FLUORIDE

MINT

NET WT 3.4 OZ (96.4 g)

#1 Dentist Recommended Brand┼

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

┼#1 Dentist Recommended Brand for Sensitive Teeth

Fast RELIEF* and Long Lasting Protection**

*significant pain relief in 3 days

Why use Sensodyne Rapid Relief?

Sensodyne Rapid Relief is clinically proven for fast relief of sensitivity pain. Its formula quickly creates a barrier over sensitive areas of your teeth to provide fast relief, and to help stop pain from coming back. With twice daily brushing, it builds ongoing protection from the pain of sensitive teeth. It also helps whiten enamel and prevents staining.

ALWAYS FOLLOW THE LABEL

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

©2017 GSK group of companies or its licensor. All rights reserved.

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

106026XA

NDC 0135-0621-02

new

SENSODYNE® Rapid Relief

& Long Lasting Protection**

**with twice daily brushing

FAST RELIEF TOOTHPASTE*

*Significant pain relief in 3 days

TOOTHPASTE FOR SENSITIVE TEETH & CAVITY PREVENTION

WITH FLUORIDE

MINT

NET WT 0.8 OZ (23 g)

#1 Dentist Recommended Brand for Sensitivity

9 OUT OF 10 DENTISTS’ RECOMMENDED BRAND

ALWAYS FOLLOW THE LABEL

KEEP CARTON FOR COMPLETE DRUG FACTS

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

©2017 GSK

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

106011XA

* Please review the disclaimer below.