FDA Label for Sensodyne Extra Whitening Cool Mint
View Indications, Usage & Precautions
Sensodyne Extra Whitening Cool Mint 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 Ingredients
Potassium nitrate 5%
Sodium fluoride 0.24% (0.15% w/v fluoride ion)
Purposes
Antihypersensitivity
Anticavity
Uses
• builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact.• aids in the prevention of dental cavities.
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
• do not store above 25°C (77°F)
Inactive Ingredients
water, hydrated silica, sorbitol, glycerin, pentasodium triphosphate, PEG-8, flavor, cocamidopropyl betaine, sodium methyl cocoyl taurate, titanium dioxide, xanthan gum, sodium hydroxide, sodium saccharin
Questions Or Comments?
1-866-844-2797
Additional Information
ALWAYS FOLLOW THE LABEL
What are sensitive teeth?
Lots of people have sensitive teeth. When enamel is worn away (through eating everyday acidic food or drinks) or gums recede, the dentin underneath becomes exposed. This can lead to tooth sensitivity, for example, with cold and hot food and drinks.
What does Sensodyne do?
Sensodyne provides daily care for sensitive teeth* plus all the benefits you would expect from a daily
fluoride toothpaste - strong teeth and freshness. *with twice daily brushing.
Exposed Dentin
24/7
Sensitivity Protection*
+ Strong & Healthy Teeth
Use Sensodyne Extra Whitening
Cool Mint twice dally:
• Long lasting sensitivity protection* everyday
• Contains fluoride to protect against cavities
Trademarks are owned by or licensed to the GSK group of companies.
©2022 GSK group of companies or its licensor.
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059
Principal Display Panel
SENSODYNE
#1 DENTIST RECOMMENDED BRAND
TOOTHPASTE FOR SENSITIVE TEETH AND CAVITY PREVENTION
24/7 Sensitivity Protection* + Strong & Healthy Teeth
Extra Whitening
Cool Mint
NET WT 4.0 OZ (113 g)
62000000079742 Front Carton
* Please review the disclaimer below.