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Fluoride Treatment

HIGHLIGHTS OF PRESCRIBING INFORMATIONThese highlights do not include all the information needed to use 3M ESPE Fluoride Treatment 2% Sodium Fluoride Aqueous Solution safely and effectively. See full prescribing information for Fluoride Treatment 2% Sodium Fluoride Aqueous Solution.Initial U.S. Approval INDICATIONS AND USAGEFluoride Treatment 2% Sodium Fluoride Aqueous Solution is indicated for topical application by a dental professional to aid in the prevention of dental caries. (1) DOSAGE AND ADMINISTRATION 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. (2) Instruct the patient to gently bite down for up to 4 minutes. (2) Remove tray(s) from mouth. (2) Instruct patient to avoid food, beverages, or oral rinses for 30 minutes. (2) Frequency of application depends on the caries risk level for each patient. Typical frequency of application is every 3-6 months for patients at moderate to high risk for caries. (2) DOSAGE FORMS AND STRENGTHSColorless solution containing 2% sodium fluoride for delivery in a disposable tray (3) CONTRAINDICATIONSAvoid use in patients with known hypersensitivity to fluoride. (4) WARNINGS AND PRECAUTIONS DO NOT SWALLOW. (5) Ingestion of high levels of fluoride may cause abdominal pain, weakness, tremor, spasm, or convulsions. (5) Side EffectsAllergic reactions and other idiosyncrasies have been rarely reported. (6) To report SUSPECTED ADVERSE REACTIONS, contact 3M ESPE Dental Products Division at 1-800-634-2249 or www.3MESPE.com , or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

FULL PRESCRIBING INFORMATION: CONTENTS*

1 FLUORIDE TREATMENT INDICATIONS AND USAGE
2 FLUORIDE TREATMENT DOSAGE AND ADMINISTRATION
3 DOSAGE FORMS AND STRENGTHS
4 FLUORIDE TREATMENT CONTRAINDICATIONS
5 WARNINGS AND PRECAUTIONS
6 FLUORIDE TREATMENT ADVERSE REACTIONS
8 USE IN SPECIFIC POPULATIONS
10 OVERDOSAGE
11 FLUORIDE TREATMENT DESCRIPTION
12 CLINICAL PHARMACOLOGY
15 REFERENCES
16 HOW SUPPLIED/STORAGE AND HANDLING

FULL PRESCRIBING INFORMATION

1 INDICATIONS AND USAGE

Fluoride Treatment 2% Sodium Fluoride Aqueous Solution is indicated for topical application by a dental professional to aid in the prevention of dental caries.

2 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

3 DOSAGE FORMS AND STRENGTHS

Colorless solution containing 2% sodium fluoride for delivery in a disposable tray

4 CONTRAINDICATIONS

Avoid use in patients with known hypersensitivity to fluoride.

5 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.

6 ADVERSE REACTIONS

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.

8 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.

10 OVERDOSAGE

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.

11 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.

12 CLINICAL PHARMACOLOGY

Fluoride delivered from Fluoride Treatment inhibits caries formation by reducing enamel solubility and enhancing remineralization.

15 REFERENCES

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.

16 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).

Storage

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.

Manufactured by:
3M ESPE Dental Products
2510 Conway Avenue
St. Paul, MN 55144-1000 U.S.A.

Revision date: April 2013
Rx Only

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)

Questions? 1-800-634-2249

Made in U.S.A. for
3M ESPE, Dental Products
2510 Conway Avenue
St. Paul, MN 55144-1000 USA

REF 12195
LOT EXD-819