Sun Labs warning letter
This article was originally published in The Rose Sheet
Executive Summary
Acnoderm Acne Lotion and Bath and Body Tar Emulsion are unapproved new drugs due to labeling claims, FDA tells firm in a Jan. 14 warning letter. The letter cites labeling claims including "Active ingredient: 2% Salicylic Acid" and "For Symptomatic Relief of itching and irritation associated with Psoriasis and Eczema...Active Ingredient: 7.5% Coal Tar Solution." In addition, the products are misbranded because they fail to bear adequate directions for use, the agency says