Important Safety Information

The Responsibility of the Professional

Phocal disks have been developed for use only by licensed professionals in the dental care setting. Phocal Therapy warrants the quality of the products for the uses described and when used in the manners outlined here and in our sales and delivery documents. It is the responsibility of the professional to use the products in such manner.

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.

Safety Warnings

  • In rare cases, sensitivity or adverse reactions may be experienced. In such cases immediately remove the disks while preventing swallowing and refer the patient to a physician.
  • Patients less than 12 years old and patients with special needs should remain under professional supervision until the Phocal disks have biodegraded or have been removed.
  • Phocal disks are not intended for systemic ingestion and should be kept out of children’s reach. If more than 20 disks are accidently swallowed, seek immediate medical assistance.
  • Phocal should not be applied in sites with: gingival inflammation, immediately prior to or after oral soft tissue surgery and in cases of known allergies to any of the Phocal ingredients.
  • When Phocal treatment is utilized, routine systemic and topical administrations of fluoride should be suspended during the day of application.
  • If multiple applications are necessary, treat no more than eight sites at a time, and delay subsequent Phocal applications for 24 hours.
  • Phocal disks are to be sold as unbroken boxes with all disks sealed within the blister packs and should be used for application in the dental office by professionals only.
  • Since the propolis wax and gelatin used in Phocal disks are natural products, they may occasionally interact to produce brownish spots or discoloration. This does not indicate that there is any hazard or danger in using the product.
  • Recommended storage temperatures are 42°F - 78°F (5°C - 25°C).
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