VividSensiGuard Prescribing Information

Package insert / product label
Generic name: sodium fluoride
Dosage form: gel, dentifrice
Drug class: Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Jun 21, 2022.

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.

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

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VividSensiGuard sodium fluoride gel, dentifrice

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL 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 1 NDC:29494-1105-2 56.7 g in 1 TUBE

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 LABEL 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 1 NDC:29494-1104-2 56.7 g in 1 TUBE

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)

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