FDA Label for Sensodyne Rapid Relief
View Indications, Usage & Precautions
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.