VividSensiGuard

VIVIDSENSIGUARD- sodium fluoride gel, dentifrice
Pearson Dental Supply Co.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

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VIVIDSENSIGUARD
sodium fluoride gel, dentifrice
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:29494-1105
Route of Administration ORAL, DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 11 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
XYLITOL
CARBOXYMETHYLCELLULOSE
TRIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
SODIUM PHOSPHATE, DIBASIC
GLYCERIN
SODIUM BENZOATE
SUCRALOSE
SODIUM PHOSPHATE, MONOBASIC
WATER
TITANIUM DIOXIDE
Product Characteristics
Color Score
Shape Size
Flavor MINT Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29494-1105-2 56.7 g in 1 TUBE None
Image of Product
(click image for full-size original)
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 DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 11 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
XYLITOL
CARBOXYMETHYLCELLULOSE
SODIUM BENZOATE
TITANIUM DIOXIDE
SUCRALOSE
SODIUM PHOSPHATE, MONOBASIC
TRIBASIC CALCIUM PHOSPHATE
SILICON DIOXIDE
SODIUM PHOSPHATE, DIBASIC
Product Characteristics
Color Score
Shape Size
Flavor BUBBLE GUM Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:29494-1104-2 56.7 g in 1 TUBE None
Image of Product
(click image for full-size original)
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)

Revised: 07/2016 Pearson Dental Supply Co.

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