Mineral oil
This article was originally published in The Tan Sheet
Executive Summary
FDA denies January 1991 petition submitted by CooperVision asking that the agency increase the upper concentration limit for mineral oil and light mineral oil as OTC ophthalmic emollients from 50% to 70%. In a letter, the agency noted that "adequate safety and effectiveness data need to be developed and submitted for review" before the March 1988 final monograph for OTC ophthalmic drugs can be amended