Warning Letters: Ibuprofen Topical Drugs

ibuprofen200mg16The FDA has warned eight companies about their marketing of unapproved over-the-counter topical agents containing the pain reliever ibuprofen drugs. The letters advise the companies that they may not continue to market their products without FDA approval.

Orally administered  generic  ibuprofen has been approved as safe and effective for pain and inflammation, but there are no approved applications for topical ibuprofen. The topical form is often promoted as a safer alternative to oral ibuprofen drags.

The products are Emuprofen (buy ) (Progressive Emu), BioEntopic 15% Ibuprofen Creme (BioCentric), Ibunex Topical Ibuprofen (Core), LoPain AF 15% Ibuprofen Creme (Geromatrix), IB-Relief (Mekt), Profen HP (Ridge), IbuPro-10
Plus (Meditrend, Inc., dba Progena Professional Formulations), and Ibu-Relief 12 (Wonder).

Source: FDA, August 20, 2009