In Brief: Stef International warning letter
This article was originally published in The Tan Sheet
Executive Summary
Stef International warning letter: Kerasal claims that the product is intended to treat corns and calluses and contains salicylic acid, urea, petrolatum, glycerin, PEG-8, polysorbate-80, PEG-40 stearate and PEG-40 sorbitan peroleate make the product an unapproved drug, FDA's Detroit, Mich. district office says in an April 7 warning letter. The product labeling and formulation fail to meet the requirements of the final rule for corn and callus remover OTC drugs, FDA notes. Also, the product does not bear adequate directions for use, nor does it include an active ingredient declaration, which causes the drug to be misbranded...