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Fluoride Treatment
  • Professionals
  • FDA PI

Fluoride Treatment

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

Contraindications

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.

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.
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