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FDA halts marketing of topical ibuprofen products

Noting that topical ibuprofen drugs are not included in any OTC monograph or the subject of any approved NDA, the FDA has issued warning letters (click hyperlink to FDA warning letter) to eight manufacturers/distributors.  This action is continuing good news to DESI producers who worry that getting an NDA may not cause FDA to remove non-NDA products.

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)
Profen HP (Ridge Medical Products)
IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
IBU-RELIEF 12 (Wonder Laboratories)

Some of the claims (web site and/or product label) cited by FDA to be unlawful include:

“does not cause the side effects that sometimes come with the oral medication”

“Get relief from inflamed tendons, ligaments, muscles and joints due to sports injuries, sprains, strains and bruises, as well as the pain of arthritis, backache, muscle spasms, bursitis, TMJ, heel spurs and gout. …”

“Our 15% Ibuprofen Cream is an all-natural rich body moisturizing formula that includes MSM, Arnica flower and Devil’s Claw Root for the most powerful synergistic complex available.”

“Ibunex is a topical formula that includes Ibuprofen with Glucosamine Sulfate, Chondroitin Sulfate, MSM and Bromelain. It should be considered a first offense during the acute phase for muscle and joint application. ”


“Profen HP is a fast-acting pain relief ibuprofen topical cream used to treat: … Acute Pain – Chronic Pain – Arthritis – Soreness – Plantar Fascitis
(sic) – Tennis Elbow – Carpal Tunnel – Shin Splints – Ankle Sprains – Hand Stiffness”