Phos-flur Recall

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Questions & Answers

Side Effects & Adverse Reactions

Prolonged daily ingestion may result in various degrees of dental fluorosis in pediatric patients under age 6 years, especially in the areas with high fluoride concentration in drinking water. Use in pediatric patients under age 6 years requires special supervision to prevent repeated swallowing of gel. Use cautiously in patients with porcelain or ceramic restorations as per PRECAUTIONS below. Read directions carefully before using. Keep out of reach of infants and children.

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


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.


There is currently no drug history available for this drug.

Other Information

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 Manufacturers

  • Colgate Oral Pharmaceuticals, Inc.
    Phos-flur (Sodium Fluoride) Gel, Dentifrice [Colgate Oral Pharmaceuticals, Inc.]

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