FDA Label for Sensodyne Complete Protection
View Indications, Usage & Precautions
Sensodyne Complete Protection 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, Antigingivitis, Antihypersensitivity
Uses
• aids in the prevention of dental cavities• helps interfere with harmful effects of plaque associated with gingivitis• 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• gingivitis, bleeding, or redness persists for more than 2 weeks• you have painful or swollen gums, pus from the gum line, loose teeth, or increasing spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease.
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
glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, sodium saccharin, cocamidopropyl betaine
Inactive Ingredients (Extra Fresh)
glycerin, PEG-8, hydrated silica, pentasodium triphosphate, sodium lauryl sulfate, flavor, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin
Questions Or Comments?
call toll-free 1-866-844-2797 (English/Spanish) weekdays
Principal Display Panel
NDC 0135-0573-02
SENSODYNE®
COMPLETE PROTECTION™
WITH FLUORIDE
SENSITIVITY TOOTHPASTE WITH CAVITY & GINGIVITIS PROTECTION
9 OUT OF 10 DENTISTS RECOMMENDED BRAND
#1 Dentist Recommended Brand
NET WT 3.4 OZ (96.4 g)
SENSITIVITY
CLEAN
GUMS
FRESH
PLAQUE
ENAMEL
WHITENING
#1 Dentist Recommended Brand
COMPLETE DAILY TOOTHPASTE
What is tooth sensitivity?
Sensitivity can be a sign that your teeth are vulnerable, as dentin becomes exposed due to enamel loss or gum recession. When exposed dentin comes into contact with hot or cold, sweet or sour, or even you toothbrush, the nerve inside the tooth can be triggered, causing a short, sharp pain.
FRESH FEELING
PROTECTS ENAMEL
HELPS WHITEN ENAMEL
PROTECTS AGAINST PLAQUE
BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS TO SHIELD YOU FROM PAIN*
CLEAN FEELING
HELPS PREVENT GINGIVITIS
*With twice daily brushing
Why use Sensodyne Complete Protection™ toothpaste?
This formulation has been specifically developed to deliver all the toothpaste benefits your sensitive teeth need. Brush twice a day with Sensodyne Complete Protection™ toothpaste.
ALWAYS FOLLOW THE LABEL
SENSODYNE and the rings device are registered trademarks of the GSK group of companies.
©2015 GSK group of companies
Distributed by:
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
104050XB
NDC 0135-0572-02
SENSODYNE®
EXTRA FRESH
COMPLETE PROTECTION™
SENSITIVITY TOOTHPASTE WITH CAVITY & GINGIVITIS PROTECTION
COMPLETE DAILY TOOTHPASTE
9 OUT OF 10 DENTISTS RECOMMENDED BRAND
#1 Dentist Recommended Brand
NET WT 3.4 OZ (96.4 g)
SENSITIVITY
CLEAN
GUMS
FRESH
PLAQUE
ENAMEL
WHITENING
What is tooth sensitivity?
Sensitivity can be a sign that your teeth are vulnerable, as dentin becomes exposed due to enamel loss or gum recession. When exposed dentin comes into contact with hot or cold, sweet or sour, or even you toothbrush, the nerve inside the tooth can be triggered, causing a short, sharp pain.
FRESH FEELING
PROTECTS ENAMEL
HELPS WHITEN ENAMEL
PROTECTS AGAINST PLAQUE
BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS TO SHIELD YOU FROM PAIN*
CLEAN FEELING
HELPS PREVENT GINGIVITIS
*With twice daily brushing
Why use Sensodyne Complete Protection™ toothpaste?
This formulation has been specifically developed to deliver all the toothpaste benefits your sensitive teeth need. Brush twice a day with Sensodyne Complete Protection™ toothpaste.
ALWAYS FOLLOW THE LABEL
SENSODYNE and the rings device are registered trademarks of the GSK group of companies.
©2015 GSK group of companies
Distributed by:
GlaxoSmithKline
Consumer Healthcare, L.P.
Moon Township, PA 15108
104052XB
* Please review the disclaimer below.