Drugplain

SmileSense .11 g/100g

Stannous Fluoride · PASTE, DENTIFRICE · SGII, INC

No Recall History
Plain English

SmileSense is a paste, dentifrice containing stannous fluoride at .11 g/100g, taken dental. Manufactured by SGII, INC.

Key Facts

Brand Name
SmileSense
Generic Name
Stannous Fluoride
NDC Code (Product)
72644-639
Manufacturer
SGII, INC
Strength
.11 g/100g
Dosage Form
PASTE, DENTIFRICE
Route
DENTAL
Marketing Status
Application #
M021
Marketing Start
07/01/2024

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

oral discomfort5 reports
dyspnoea4 reports
oral disorder4 reports
oral pain4 reports
anaemia3 reports
fatigue3 reports
gingival discomfort3 reports
nausea3 reports
off label use3 reports
platelet count decreased3 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Uses Aids in the prevention of cavities Helps prevent gingivitis Helps interfere with the harmful effects of plaque associated with gingivitis Builds increasing protection against painful sensitivity of the teeth to cold, heat, acids, sweets, or contact

Dosage & Administration

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. In the AM & PM, for up to 2 minutes, gently brush your teeth using small, circular motions or as recommended by a dentist or doctor. Work your way slowly around your mouth, addressing every area of the teeth (outer, inside & chewing surface) including all sensitive areas. Open wide and angle your toothbrush toward the gum line. Rinse your mouth & toothbrush. With fresh toothpaste, brush the surface of your tongue, with reaching as far as comfortable into your mouth. Rinse again. Follow-up by flossing between all your teeth at least once a day. Do not swallow children under 12 yeasr: ask a dentist

Warnings

Warnings When using this product, do not use for sensitivity longer than four weeks unless recommended by a dentist. Stop use and ask a dentist if the sensitivity problem persists or worsens. Sensitive teeth may indicate a serious problem that may need prompt care. gingivitis, bleeding, or redness persists for more than 2 weeks. you have painful or swollen gums, pus from the gum line, loose teeth, or increased spacing between the teeth. These may be signs or symptoms of periodontitis, a serious form of gum disease. Keep out of reach of children, under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Frequently Asked Questions

What is SmileSense used for?

SmileSense contains Stannous Fluoride. It is a paste, dentifrice taken dental. Consult your doctor for specific uses.

Is SmileSense a controlled substance?

SmileSense is not classified as a controlled substance by the DEA.

What is the generic name for SmileSense?

The generic name for SmileSense is Stannous Fluoride. There are 11 other brand versions of Stannous Fluoride.

What is the NDC code for SmileSense .11 g/100g?

The NDC (National Drug Code) for SmileSense .11 g/100g is 72644-639, listed by SGII, INC.