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  5. Label Information: Sensodyne Rapid Relief

FDA Label for Sensodyne Rapid Relief

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSES
    3. USES
    4. WHEN USING THIS PRODUCT,
    5. STOP USE AND ASK A DENTIST IF
    6. KEEP OUT OF REACH OF CHILDREN.
    7. DIRECTIONS
    8. OTHER INFORMATION
    9. INACTIVE INGREDIENTS (EXTRA FRESH)
    10. INACTIVE INGREDIENTS (MINT)
    11. QUESTIONS OR COMMENTS?
    12. PRINCIPAL DISPLAY PANEL

Sensodyne Rapid Relief Product Label

The following document was submitted to the FDA by the labeler of this product Haleon Us Holdings Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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.