Several drug companies marketing over the counter topical Ibuprofen pain gels have been sent warning letters from the FDA. According to the federal regulatory agency, such OTC pain gels require pre-marketing approval from the FDA. The letter informed the drug companies that they must stop marketing their products until they receive approval from the FDA.
Companies that received the FDA warning letter include:
Emuprofen (Progressive Emu, Inc.)
BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)
Ibunex Topical Ibuprofen (Core Products International, Inc.)
LoPain AF 15% Ibuprofen Crème (Geromatrix Health Products)
IB-RELIEF (MEKT LLC)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)
These products contain ibuprofen in combination with other active ingredients and are marketed for pain relief. Thus far, the FDA has not approved any topical ibuprofen drugs.
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