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| Product NDC Code | 72644-639 | ||||
|---|---|---|---|---|---|
| Drug Name | Smilesense |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | DENTAL | ||||
| Dosage Form | PASTE, DENTIFRICE | ||||
| RxCUI drug identifier | 416784 | ||||
| Application Number | M021 | ||||
| Labeler Name | SGII, INC | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Stannous Fluoride 0.454% (0.18% W/V Fluoride Ion)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.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
Purpose
Information about the drug product’s indications for use.Purpose Stannous Fluoride 0.454% (0.18% W/V Fluoride Ion).................Anticavity, Antigingivitis, Antisensitivity
Spl product data elements
Usually a list of ingredients in a drug product.SmileSense Stannous Fluoride GARDENIA JASMINOIDES WHOLE GLYCYRRHIZIN XANTHAN GUM CARBON DIOXIDE MEDIUM-CHAIN TRIGLYCERIDES CARVONE, (+)- POTASSIUM CITRATE POLYOXYL 40 HYDROGENATED CASTOR OIL ZINC CITRATE SIRAITIA GROSVENORII FRUIT SORBITOL SODIUM BICARBONATE ERYTHRITOL MENTHOL PEPPERMINT OIL SODIUM BENZOATE WATER SODIUM CHLORIDE .GAMMA.-TERPINENE ISOMALT HYDRATED SILICA XYLITOL MALTODEXTRIN REBAUDIOSIDE A LIMONENE, (+)- SODIUM LAUROYL SARCOSINATE SPEARMINT OIL SACCHARIN SODIUM POTASSIUM BITARTRATE ALCOHOL TITANIUM DIOXIDE STANNOUS FLUORIDE FLUORIDE ION
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.SmileSense with BritePop Technology Anticavity, Antigingivitis and Antisensitivity Fluoride Toothpaste 3.8 oz / 108 g 1
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.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.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? +1 949-860-1860
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product, do not use for sensitivity longer than four weeks unless recommended by a dentist.
Storage and handling
Information about safe storage and handling of the drug product.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.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API