Generic Name: sodium fluoride
Dosage Form: oral solution
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.
Indications and Usage for Fluoride Treatment
Fluoride Treatment 2% Sodium Fluoride Aqueous Solution is indicated for topical application by a dental professional to aid in the prevention of dental caries.
Fluoride Treatment Dosage and Administration
- Instruct patient to open mouth. Insert the tray(s) into the patient's mouth, seating the solution portion of the tray over the teeth. Ensure tray adequately covers patient's dentition. Instruct the patient to tilt the head slightly forward.
- Instruct the patient to gently bite down for up to 4 minutes. Suction may be used throughout treatment but is not necessary.
- Remove tray(s) from mouth and dispose of used trays in medical waste. Residual solution left in the mouth should be expectorated and/or adequately suctioned.
- Instruct the patient to avoid food, beverages, or oral rinses for 30 minutes.
- Frequency of application depends on the caries risk level for each patient. Recommendations for patients at moderate to high risk for caries include professional topical fluoride application every 3-6 months.1
Dosage Forms and Strengths
Colorless solution containing 2% sodium fluoride for delivery in a disposable tray
Avoid use in patients with known hypersensitivity to fluoride.
Warnings and Precautions
- DO NOT SWALLOW.
- Ingestion of high levels of fluoride may cause abdominal pain, weakness, tremor, spasm, or convulsions.
- There have been no long term studies with this product to evaluate carcinogenic, mutagenic or impairment of fertility potential.
- Allergic reactions and other idiosyncrasies have been rarely reported.
- Developing teeth of children under age 6 may become permanently discolored if excessive amounts of fluoride are repeatedly swallowed.
USE IN SPECIFIC POPULATIONS
No studies of Fluoride Treatment have been conducted to determine whether pediatric, geriatric, pregnant, or nursing mothers respond differently from other subjects.
Ingestion of high levels of fluoride may result in abdominal pain, weakness, tremor, spasm, or convulsions. These symptoms may occur at overdosage of 5 mg/kg of body weight. Fluoride doses of 16 mg/kg have been fatal.2
One upper and one lower medium size tray filled with Fluoride Treatment contain a total of 42.9 mg of fluoride. If an average 6 year old child who weighs 22.6 kg (approximately 50 pounds) would swallow all the Fluoride Treatment contained in both upper and lower medium size trays, he or she would receive a fluoride dose equivalent to 1.9 mg/kg. This dose is 2.6 times less than the level that can begin to cause adverse effects.
Fluoride Treatment Description
Fluoride Treatment is a professionally-applied fluoride solution for delivery in a disposable tray for the prevention of dental caries. Each gram of solution contains fluoride (9 mg), xylitol, and tri-calcium phosphate in a neutral pH base.
Fluoride Treatment - Clinical Pharmacology
Fluoride delivered from Fluoride Treatment inhibits caries formation by reducing enamel solubility and enhancing remineralization.
- ADA Council on Scientific Affairs. Professionally applied topical fluoride: Executive summary of evidence-based clinical recommendations. JADA 2006 or www.ada.org/goto/ebd
- Poisindex. Toxicologic Management – Fluoride. Thomson Micromedex.
How Supplied/Storage and Handling
Fluoride Treatment is supplied as a colorless solution for delivery in a disposable tray. Fluoride Treatment is available in Bubble Gum Flavor (NDC 48878-3160-2).
This product is designed to be stored and used at room temperature. Do not freeze or expose to extreme heat. See outer package for expiration date.
3M ESPE Dental Products
2510 Conway Avenue
St. Paul, MN 55144-1000 U.S.A.
Revision date: April 2013
3M and ESPE are trademarks of 3M or 3M Deutschland GmbH.
Principal Display Panel – Box Label
3M ESPE NDC 48878-3160-2
Fluoride Treatment Rx Only
2% Sodium Fluoride Aqueous Solution Bubble Gum
Active Ingredient: Sodium fluoride (9049 ppm F-) 2.0% w/w (0.93 % w/v fluoride ion)
Indication and Use: Indicated for single use, topical application by a dental professional to aid in the prevention of dental caries.
Warnings: DO NOT SWALLOW. Keep out of reach of children under 6 years of age. Read full prescribing information before using this product. Do not freeze or expose to extreme heat.
Inactive Ingredients: flavor; tricalcium phosphate, water, xylitol, other ingredients in a neutral pH base
Contents: NET WT 0.17 oz. (4.75 grams)
3M and ESPE are trademarks
of 3M or 3M Deutschland GmbH.
Used under license in Canada.
© 3M 2013. All rights reserved
Made in U.S.A. for
3M ESPE, Dental Products
2510 Conway Avenue
St. Paul, MN 55144-1000 USA
sodium fluoride solution
|Labeler - 3M ESPE Dental Products (799975909)|
|3M ESPE Dental Products||078404534||MANUFACTURE(48878-3160)|
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