Label: VIVIDSENSIGUARD- sodium fluoride gel, dentifrice
VIVIDSENSIGUARD- sodium flouride gel, dentifrice

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated July 7, 2016

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  • Active Ingredient

    Sodium Fluoride 1.1%

    (0.5% Fluoride Ion)

  • Indications

    Self-topical neutral 1.1% sodium fluoride for use as a dental caries and hypersensitivity preventative in adults and pediatric patients.

  • Directions

    Adults and children six years of age and older should brush with Vivid SensiGuard™ gel once at bedtime (or as directed). Apply a thin bead of gel to toothbrush and brush for at least one minute, making sure all tooth surfaces are covered. ADULTS: expectorate thoroughly. Do not rinse, drink or eat for at least 30 minutes after use. CHILDREN SIX YEARS OF AGE AND OLDER: expectorate and rinse thoroughly. If recommended by your dental professional, this product can be used in place of your regular toothpaste. Read all instructions and prescribing information before using this product.

  • Warning

    Do not swallow. To avoid ingestion, supervision is required while children are using this product. Swallowing excessive amounts of fluoride could cause dental fluorosis. KEEP OUT OF REACH OF CHILDREN AND INFANTS.

  • Precautions

    Federal (U.S.A.) Law prohibits dispensing without prescription. Store at controlled room temperature 68º - 77º F (20ºC - 25ºC).

    Reorder # M09-1104

    Reorder # M09-1105

    Manufactured in U.S.A.


    Distributed by: Pearson Dental

    Sylmar, CA 91342 U.S.A.

  • Inactive Ingredients

    Purified Water, Glycerin, Carboxymethyl Cellulose, Xylitol, Sodium Benzoate, Titanium Dioxide, Sucralose, Sodium Phosphate Monobasic, Calcium Hydroxyapetite, Silica, Sodium Phosphate Dibasic, Flavors.

  • VIVIDSENSIGUARD

    bubble gum.jpg

    mint.jpg bubble gumMint

  • INGREDIENTS AND APPEARANCE
    VIVIDSENSIGUARD 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:29494-1105
    Route of AdministrationORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION11 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    WATER (UNII: 059QF0KO0R)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorMINTImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29494-1105-256.7 g in 1 TUBE; Type 0: Not a Combination Product06/13/2016
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/13/2016
    VIVIDSENSIGUARD 
    sodium flouride gel, dentifrice
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:29494-1104
    Route of AdministrationORAL, DENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION11 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    XYLITOL (UNII: VCQ006KQ1E)  
    CARBOXYMETHYLCELLULOSE (UNII: 05JZI7B19X)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    SODIUM PHOSPHATE, MONOBASIC (UNII: 3980JIH2SW)  
    TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:29494-1104-256.7 g in 1 TUBE; Type 0: Not a Combination Product06/13/2016
    Image of Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other06/13/2016
    Labeler - Pearson Dental Supply Co. (082874108)
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