Sodium Fluoride 1.1% Dental Gel BUBBLEGUM SODIUM FLUORIDE IPG PHARMACEUTICALS, INC. FDA Approved Uses This is a fluoride dental gel intended for use as a dental caries preventive in adults and pediatric patients.
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Substance Sodium Fluoride
Route
ORAL
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active Ingredient 1.1% neutral sodium fluoride
Inactive Ingredients
Inactive ingredient Water Glycerin Hydrated Silica Calcium Carbonate Xylitol Sorbitol Xanthan Gum Flavor Yucca Shidigera Root Extract Quillaja Saponaria Bark Extract Smilax Aristolochiaefolia Root Extract Dioscorea Villosa Root Extract Tocopheryl Acetate Cocamidopropyl Betaine Benzyl Alcohol.
Strengths
1.1 %
Treats Conditions
Uses This Is A Fluoride Dental Gel Intended For Use As A Dental Caries Preventive In Adults And Pediatric Patients

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
8ZYQ1474W7
Packaging

Product label image description image description

Package Descriptions
  • Product label image description image description

Overview

Uses This is a fluoride dental gel intended for use as a dental caries preventive in adults and pediatric patients.

Indications & Usage

Uses This is a fluoride dental gel intended for use as a dental caries preventive in adults and pediatric patients.

Dosage & Administration

Directions Use twice a day (morning and evening) in place of regular toothpaste or as recommended by a dentist or a physician. Adults and Children 6 Years of Age and Older : Twist off cap and remove foil seal. Apply at least a1-inch strip of gel onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute. Spit out and rinse mouth thoroughly. Make sure to brush all sensitive areas of the teeth. Dosage form and Strengths : Dental gel containing 1.1% sodium fluoride.

Warnings & Precautions
Warning Contraindications : Avoid use in patients with known hypersensitivity to fluoride. Do not use in pediatric patients under 6 unless directed by a dentist or physician. Warnings and Precautions: Do no swallow. Keep out of reach of children. Read the prescribing information fully before using this product. If the product is accidentally swallowed in quantities greater than would normally occur with a toothpaste, seek medical help right away. See your dentist if the problem persists or worsens. Do not use this product longer than 4 weeks unless recommended by a dentist or physician. Adverse reactions: To report suspected Adverse reactions , To report suspected adverse reactions, contact IPG Pharmaceuticals at (888) 711-7116 or the FDA at (800) FDA-1088 or www.fda.gov/medwatch.
Purpose

Sodium Fluoride Dental Gel 1.1% is a flavored, pH neutral 1.1% sodium fluoride that aids in the prevention of dental decay and helps to treat sensitive teeth.


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