Del Pharmaceuticals
This article was originally published in The Tan Sheet
Executive Summary
Introducing reformulated Boil-Ease, which contains 20% benzocaine and is indicated for use twice daily over three days. The new product replaces a 5% benzocaine formulation and is expected to comply with FDA's OTC external analgesics monograph. Del proposed dosing at three-to-four-times daily over seven days, but FDA rejected that dosing schedule at an April "OTC feedback" meeting ("The Tan Sheet" April 25, p. 4)