FDA Label for Sensodyne Sensitivity Gum And Enamel Mint
View Indications, Usage & Precautions
Sensodyne Sensitivity Gum And Enamel 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.
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 specially formulated to help prevent staining.• do not store above 25°C (77°F)
Inactive Ingredients
glycerin, PEG-8, hydrated silica, pentasodium triphosphate, flavor, sodium lauryl sulfate, titanium dioxide, polyacrylic acid, cocamidopropyl betaine, sodium saccharin, silica
Questions Or Comments?
1-866-844-2797
Additional Information
ALWAYS FOLLOW THE LABEL
SENSODYNE
SENSITIVITY
GUM &
ENAMEL
Gum recession and enamel wear are the two leading causes of sensitive teeth. Gum problems are caused by a build-up of plaque bacteria along the gum line. Enamel wear can be caused by acids in
everyday foods and drinks.
Sensodyne Sensitivity, Gum & Enamel is a daily toothpaste with a clinically proven ingredient to relieve sensitive teeth and improve gum health, while also strengthening the enamel.
1. Builds a protective layer over the sensitive areas
2. Formula with stannous fluoride targets & removes plaque bacteria** in between teeth & gumline.
3. Strengthens enamel surface and protects teeth from acids, while being gentle on enamel.
*with twice daily brushing.
**plaque bacteria associated with gingivitis to help reduce swollen, bleeding gums.
Trademarks owned or licensed by GSK. @2022 GSK or licensor.
Distributed by: GSK Consumer Healthcare
Warren, NJ 07059. Made in Germany
CARTON
RECYCLE
Principal Display Panel
new
#1 Dentist RecommendED Brand
SENSODYNE
MINT
SENSITIVITY GUM & ENAMEL
FLUORIDE TOOTHPASTE FOR SENSITIVE TEETH,
ANTI-GINGIVITIS AND CAVITY PREVENTION
NEW WT 3.4 OZ (96.4 g)
20041 Front Carton
* Please review the disclaimer below.