FDA Label for Sensodyne Sensitivity And Gum Mint
View Indications, Usage & Precautions
Sensodyne Sensitivity And Gum 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 Ingredient
Stannous fluoride 0.454% (0.15% w/v fluoride ion)
Purposes
Anticavity, Antigingivitis, Antihypersensitivity
Uses
• aids in the prevention of dental cavities.• helps control bleeding gums.• 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 maybe 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 (Sensitivity & Gum Whitening)
glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin
Inactive Ingredients (Sensitivity & Gum Mint)
glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin
Questions Or Comments?
1-866-844-2797
Principal Display Panel
NDC 0135-5024-01
new
SENSODYNE
WITH FLUORIDE
SENSITIVITY & GUM
IMPROVES GUM HEALTH
WHITENING
LOW ABRASION FORMULA
DUAL ACTION TOOTHPASTE
TOOTHPASTE FOR SENSITIVE TEETH, GINGIVITIS AND CAVITY PREVENTION
NET WT 3.4 OZ (96.4g)
#1 Dentist Recommended Brand for Sensitive Teeth
Why use Sensodyne Sensitivity & Gum?
Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity & improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste.
SENSITIVE AREAS AND SWOLLEN BLEEDING GUMS
BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS
TARGETS & HELPS REMOVE PLAQUE BACTERIA
RELIEVES TOOTH SENSITIVITY* & IMPROVES GUM HEALTH
*with twice daily brushing
Dual Action forTOOTH SENSITIVITY & GUM PROBLEMS
ALWAYS FOLLOW THE LABEL
Trademarks are owned by or licensed to the GSK group of companies.
©2019 GSK group of companies or its licensor.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
62000000039060
NDC 0135-5023-01
new
SENSODYNE
WITH FLUORIDE
SENSITIVITY & GUM
IMPROVES GUM HEALTH
MINT
LOW ABRASION FORMULA
DUAL ACTION TOOTHPASTE
TOOTHPASTE FOR SENSITIVE TEETH, GINGIVITIS AND CAVITY PREVENTION
NET WT 3.4 OZ (96.4 g)
#1 Dentist Recommended Brand for Sensitive Teeth
Why use Sensodyne Sensitivity & Gum?
Sensodyne Sensitivity & Gum contains a clinically proven ingredient to relieve tooth sensitivity & improve gum health. It builds a protective layer over sensitive areas, effectively relieving tooth sensitivity. It targets and removes plaque bacteria associated with gingivitis, to help reduce swollen, bleeding gums. You can deal with both these concerning problems with one specialist toothpaste. Sensodyne Sensitivity & Gum is a daily fluoride toothpaste.
SENSITIVE AREAS AND SWOLLEN BLEEDING GUMS
BUILDS A PROTECTIVE LAYER OVER SENSITIVE AREAS
TARGETS & HELPS REMOVE PLAQUE BACTERIA
RELIEVES TOOTH SENSITIVITY* & IMPROVES GUM HEALTH
*with twice daily brushing
Dual Action forTOOTH SENSITIVITY & GUM PROBLEMS
ALWAYS FOLLOW THE LABEL
Trademarks are owned by or licensed to the GSK group of companies.
©2019 GSK group of companies or its licensor.
Distributed by:
GSK Consumer Healthcare
Warren, NJ 07059
62000000039090
* Please review the disclaimer below.