Label: SMILESENSE- stannous fluoride paste, dentifrice

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated July 1, 2024

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  • Active ingredient

    Stannous Fluoride 0.454% (0.18% W/V Fluoride Ion)

  • 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
  • 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.

  • 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

  • PRINCIPAL DISPLAY PANEL

    SmileSense

    with BritePop Technology

    Anticavity, Antigingivitis and Antisensitivity

    Fluoride Toothpaste

    3.8 oz / 108 g

    1

  • INGREDIENTS AND APPEARANCE
    SMILESENSE 
    stannous fluoride paste, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72644-639
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    STANNOUS FLUORIDE (UNII: 3FTR44B32Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.11 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    GARDENIA JASMINOIDES WHOLE (UNII: 0PK353KHF0)  
    GLYCYRRHIZIN (UNII: 6FO62043WK)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    CARBON DIOXIDE (UNII: 142M471B3J)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    CARVONE, (+)- (UNII: 4RWC1CMS3X)  
    POTASSIUM CITRATE (UNII: EE90ONI6FF)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    ZINC CITRATE (UNII: K72I3DEX9B)  
    SIRAITIA GROSVENORII FRUIT (UNII: NOU2FB51TW)  
    SORBITOL (UNII: 506T60A25R)  
    SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
    ERYTHRITOL (UNII: RA96B954X6)  
    MENTHOL (UNII: L7T10EIP3A)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM CHLORIDE (UNII: 451W47IQ8X)  
    .GAMMA.-TERPINENE (UNII: 4YGF4PQP49)  
    ISOMALT (UNII: S870P55O2W)  
    HYDRATED SILICA (UNII: Y6O7T4G8P9)  
    XYLITOL (UNII: VCQ006KQ1E)  
    MALTODEXTRIN (UNII: 7CVR7L4A2D)  
    REBAUDIOSIDE A (UNII: B3FUD0528F)  
    LIMONENE, (+)- (UNII: GFD7C86Q1W)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    SPEARMINT OIL (UNII: C3M81465G5)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    POTASSIUM BITARTRATE (UNII: NPT6P8P3UU)  
    ALCOHOL (UNII: 3K9958V90M)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:72644-639-01108 g in 1 TUBE; Type 0: Not a Combination Product07/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02107/01/2024
    Labeler - SGII, INC (070096792)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dynamic Blending Specialists, Inc.085704438manufacture(72644-639)
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