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

VividSensiGuard by

Drug Labeling and Warnings

VividSensiGuard by is a Prescription medication manufactured, distributed, or labeled by Pearson Dental Supply Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

INGREDIENTS AND APPEARANCE

VIVIDSENSIGUARD 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 29494-1105
Route of Administration	ORAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	11 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29494-1105-2	56.7 g in 1 TUBE; Type 0: Not a Combination Product	06/13/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/13/2016

VIVIDSENSIGUARD 
sodium flouride gel, dentifrice

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 29494-1104
Route of Administration	ORAL, DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	11 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
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
Shape		Size
Flavor	BUBBLE GUM	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29494-1104-2	56.7 g in 1 TUBE; Type 0: Not a Combination Product	06/13/2016

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/13/2016

Labeler - Pearson Dental Supply Co. (082874108)