Phocal PHN

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

Medically reviewed by Drugs.com. Last updated on Jul 22, 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.

easy interproximal therapy

INSTRUCTIONS FOR USE

Purpose and Indications

• Phocal disks are topical delivery vehicles designed to fluoridate interproximal tooth surfaces. This action aids in the prevention of dental caries on intact surfaces, arrests progress on surfaces with incipient carious lesions and enhances remineralization. Phocal disks are also effective at tooth restoration margins and furcations.
• Phocal disks are to be applied only by dental professionals at selected sites to achieve the desired benefits.

Description

• The patented Phocal topical fluoride disks are provided in two forms:

  –

  pink acidulated phosphate fluoride Apf disks

  –

  yellow non-acidic sodium fluoride pHn disks

• These thin, round disks contain 1.02% fluoride ions. Once positioned interproximally they rapidly expand, soften into a gel and release fluoride for approximately 10 minutes before biodegrading. This release period can be increased as explained in the Directions for Use.
• Each Phocal Apf disk contains 0.1135mg of sodium fluoride in a matrix of FD&C red 3, gum arabic, gelatin (of marine origin), propolis wax, phosphoric acid, sodium benzoate and water. These disks induce an optimized low pH environment that cleans and etches tooth surfaces and facilitates fluoride penetration and stimulates remineralization.
• Each Phocal PHN disk contains 0.1135mg of sodium fluoride in a matrix of gum arabic, gelatin (of marine origin), propolis wax, sodium benzoate and water. These disks are less acidic than the Phocal Apf disks and will not etch ceramic crowns or tooth-colored restorations while inducing fluoridation and remineralization.

Directions for Use

• There are different methods for the placement of Phocal fluoride disks.
• The choice of placement method and Phocal type is subject to the discretion of the dental professional and is usually dependent upon the nature of the site being treated, interproximal tightness and the strength and type of adjacent restorations and teeth.
• Prior to treatment using either of the placement methods below, all debris and calculus should be removed from the selected site(s) and the site(s) should remain dry during placement. Premature wetting softens the disks and can compromise correct interproximal placement.