Phos-Flur Gel

Generic name:sodium fluoride
Dosage form: dental gel
Drug class:Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Aug 23, 2021.

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.

1.1% Sodium Fluoride and
Acidulated Phosphate Gel

Rx ONLY

Phos-Flur Gel Description

Phos-Flur® Gel contains 0.5% fluoride ion (F-) from 1.1% sodium fluoride in an aqueous gel containing 0.1 molar phosphate, pH 5.1. For daily self-topical use as a dental caries preventative in adults and pediatric patients age 6 years and over. This prescription product is not a dentifrice.

Active Ingredient

Sodium Fluoride 1.1% (w/v).

Inactive Ingredients

butylparaben, disodium EDTA, ethylparaben, flavor, glycerin, methylparaben, PEG-12, phosphoric acid, poloxamer 407, polysorbate 20, propylene glycol, propyl paraben, sodium benzoate, sodium phosphate, sodium saccharin, water, xanthan gum, D&C yellow no. 10, FD&C blue no.1

Phos-Flur Gel - Clinical Pharmacology

Frequent topical applications to the teeth with preparations having a relatively high fluoride content increase tooth resistance to acid dissolution and enhance penetration of the fluoride ion into tooth enamel.

Indications and Usage for Phos-Flur Gel

A dental caries preventive, for once daily self-applied topical use. It is well established that 1.1% sodium fluoride in an acidulated gel is safe and extraordinarily effective as a caries preventive in orthodontic patients when applied frequently with mouthpiece applicators.1,2,3,4,5 Phos-Flur® Gel in a squeeze tube is a particularly convenient dosage form which permits the application of a thin ribbon of gel onto a toothbrush as well as a mouthpiece tray.

Contraindications

Do not use in pediatric patients under age 6 years unless recommended by a dentist or physician.

Warnings

Prolonged daily inge..