Active Ingredient
Stannous Fluoride 0.454% (0.18% W/V Fluoride Ion)
Smilesense Paste, Dentifrice
FDA Label NDC 72644-639
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Sgii, Inc for the product Smilesense (NDC 72644-639). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding active ingredient, purpose, uses, otc - when using, otc - stop use, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Stannous Fluoride 0.454% (0.18% W/V Fluoride Ion).................Anticavity, Antigingivitis, Antisensitivity
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
Otc - When Using
When using this product, do not use for sensitivity longer than four weeks unless recommended by a dentist.
Otc - Stop Use
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.
Otc - Keep Out Of Reach Of Children
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.
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
Other Information
Products containing stannous fluoride may produce surface staining of the teeth. Adequate tooth brushing may prevent these stains, which are not harmful or permanent and may be removed by your dentist.
Inactive Ingredients
Caprylic/Capric Triglyceride (Organic Coconut Oil), Isomalt, Hydrated Silica, Xylitol, Sorbitol, Sodium Bicarbonate, Erythritol, Sodium Lauroyl Sarcosinate, Flavor, Xanthan Gum, Menthol, PEG-40 Hydrogenated Castor Oil, Zinc Citrate, Mentha Piperita (Peppermint) Oil, Mentha Viridis (Spearmint) Leaf Oil, Potassium Citrate, Siraitia Grosvenorii (Monkfruit) Fruit Extract, Sodium Saccharin, Potassium Bitartrate, Carbon Dioxide, Sodium Benzoate, Water, Maltodextrin, Carvone, Rebaudioside A, Alcohol Denat., Limonene, Sodium Chloride, Hydrolyzed Gardenia Florida Extract, Glycyrrhizic Acid, Gamma-Terpinene, Titanium Dioxide.
Questions?
+1 949-860-1860
Package Label.Principal Display Panel
SmileSense
with BritePop Technology
Anticavity, Antigingivitis and Antisensitivity
Fluoride Toothpaste
3.8 oz / 108 g
* Please review the disclaimer below.
