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  5. Label Information: Sodium Fluoride 1.1% Dental Gel Bubblegum

FDA Label for Sodium Fluoride 1.1% Dental Gel Bubblegum

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. USES
    3. DIRECTIONS
    4. WARNING
    5. INACTIVE INGREDIENT
    6. PRODUCT LABEL

Sodium Fluoride 1.1% Dental Gel Bubblegum Product Label

The following document was submitted to the FDA by the labeler of this product Ipg Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Active Ingredient



1.1% neutral sodium fluoride


Uses



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


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.


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.


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.


Product Label



image description - Image 79 1

image description - Image 79 1


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