NIPA Hardwicke seeking PCMX topical antimicrobial Category I status.
This article was originally published in The Tan Sheet
Executive Summary
NIPA HARDWICKE PCMX ANTIMICROBIAL STUDY TO TEST METABOLISM of the topical ingredient, which is also called chloroxylenol, in mice in accord with guidelines established at a Sept. 22 FDA "feedback" meeting in Rockville, Md. FDA Anti-infective Drug Products Pharmacology/Toxicology Reviewer Terry Peters suggested the Wilmington, Del.-based chemical manufacturer NIPA Hardwicke should use carbon 14, a radioactive isotope, to chart the topical antimicrobial ingredient's metabolic changes during a four-week repeated application, absorption, digestion, metabolism and excretion (ADME) study.