VOCO PROFLUORID VARNISH

Additional Manufacturer Narrative

VOCO PROFLUORID VARNISH CONTAINS COLOPHONY AND ARTIFICIAL FLAVORS. INTOLERANCES TO THESE INCREDIENTS CANNOT BE RULED OUT IN RARE CASES. THE INSTRUCTION FOR USE CONTAIN APPROPRIATE WARNINGS.

Description of Event or Problem

ONE PATIENT COMPLAINED OF A BURNING SENSATION OF THE ORAL MUCOSA AND REDNESS EXTENDING TO THE NECK AREA ONE DAY AFTER TREATMENT WITH VOCO PROFLUORIDE VARNISH. HOSPITALIZATION WAS NOT REQUIRED. MEDICAL OR PHYSICIAN INTERVENTIONS AS A RESULT OF THE ALLERGIC REACTION AND THE PATIENT'S CURRENT CONDITION ARE NOT KNOWN TO THE TREATING DENTIST. THE INFORMATION COULD NOT BE OBTAINED UPON REQUEST. IN CASE OF RE-EXPOSURE TO THE VARNISH, MORE SERIOUS CONSEQUENCES FOR THE PATIENT CANNOT BE RULED OUT.