PreviDent Fresh Mint, PreviDent Very Berry SODIUM FLUORIDE COLGATE ORAL PHARMACEUTICALS, INC. FDA Approved Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in pediatric patients and adults. This prescription product is not a dentifrice. Active Ingredient Sodium Fluoride 1.1% (w/v). Inactive Ingredients Cetylpyridinium chloride, flavor, hydroxyethycellulose, poloxamer 407, sodium saccharin, sorbitol, titanium dioxide, water, FD&C blue no. 1 (FreshMint only), FD&C red no. 40 (Very Berry only)

Drug Facts

Composition & Profile

Strengths
56 g
Treats Conditions
Indications And Usage A Dental Caries Preventive For Once Daily Self Applied Topical Use It Is Well Established That 1 1 Sodium Fluoride Is Safe And Extraordinarily Effective As A Caries Preventive When Applied Frequently With Mouthpiece Applicators 1 4 Prevident Gel In A Squeeze Tube Is Easily Applied Onto A Toothbrush As Well As A Mouthpiece Tray This Prescription Dental Gel Should Be Used Once Daily Following Use Of A Regular Toothpaste Unless Otherwise Instructed By Your Dental Professional
Pill Appearance
Color: blue

Identifiers & Packaging

Container Type BOX
UNII
8ZYQ1474W7
Packaging

HOW SUPPLIED Fresh Mint Very Berry 2 oz. (56 g) net wt. plastic tubes. NDC 0126-0088-02 NDC 0126-0288-02 STORAGE Store at controlled room temperature, 68-77°F (20-25°C).; PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton - 0088 NDC 0126-0088-02 Colgate ® PreviDent ® Gel Rx Only 1.1% Sodium Fluoride NON-ABRASIVE FORMULA IS GENTLE ON TEETH AND GUMS PROFESSIONAL fresh mint 2.0 OZ (56.6 g) PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton - 0088; PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton - 0288 NDC 0126-0288-02 Colgate ® PreviDent ® Gel Rx Only 1.1% Sodium Fluoride NON-ABRASIVE FORMULA IS GENTLE ON TEETH AND GUMS PROFESSIONAL very berry 2.0 OZ (56.6 g) PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton - 0288

Package Descriptions
  • HOW SUPPLIED Fresh Mint Very Berry 2 oz. (56 g) net wt. plastic tubes. NDC 0126-0088-02 NDC 0126-0288-02 STORAGE Store at controlled room temperature, 68-77°F (20-25°C).
  • PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton - 0088 NDC 0126-0088-02 Colgate ® PreviDent ® Gel Rx Only 1.1% Sodium Fluoride NON-ABRASIVE FORMULA IS GENTLE ON TEETH AND GUMS PROFESSIONAL fresh mint 2.0 OZ (56.6 g) PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton - 0088
  • PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton - 0288 NDC 0126-0288-02 Colgate ® PreviDent ® Gel Rx Only 1.1% Sodium Fluoride NON-ABRASIVE FORMULA IS GENTLE ON TEETH AND GUMS PROFESSIONAL very berry 2.0 OZ (56.6 g) PRINCIPAL DISPLAY PANEL - 56.6 g Tube Carton - 0288

Overview

Self-topical neutral fluoride gel containing 1.1% sodium fluoride for use as a dental caries preventive in pediatric patients and adults. This prescription product is not a dentifrice. Active Ingredient Sodium Fluoride 1.1% (w/v). Inactive Ingredients Cetylpyridinium chloride, flavor, hydroxyethycellulose, poloxamer 407, sodium saccharin, sorbitol, titanium dioxide, water, FD&C blue no. 1 (FreshMint only), FD&C red no. 40 (Very Berry only)

Indications & Usage

A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride is safe and extraordinarily effective as a caries preventive when applied frequently with mouthpiece applicators. 1-4 PreviDent® Gel in a squeeze-tube is easily applied onto a toothbrush as well as a mouthpiece tray. This prescription dental gel should be used once daily following use of a regular toothpaste unless otherwise instructed by your dental professional.

Dosage & Administration

Follow these instructions unless otherwise instructed by your dental professional: After brushing thoroughly with toothpaste, rinse as usual. Adults and pediatric patients 6 years of age or older, apply a thin ribbon of gel to the teeth with a toothbrush or mouth trays once daily for at least one minute, preferably at bedtime. After use, adults expectorate gel. For best results, do not eat, drink, or rinse for 30 minutes. Pediatric patients, age 6-16 years, expectorate gel after use and rinse mouth thoroughly.

Warnings & Precautions
WARNINGS Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in the areas with high fluoride concentration in drinking water. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel. Read directions carefully before using. Keep out of reach of infants and children.
Contraindications

Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Adverse Reactions

Allergic reactions and other idiosyncrasies have been rarely reported.

Storage & Handling

STORAGE Store at controlled room temperature, 68-77°F (20-25°C).


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