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FDA Issues Warning Regarding Topical Ibuprofen Drug Products

The U.S. Food and Drug Administration (FDA) has issued warning letters to 8 companies marketing unlawful over-the-counter (OTC) topical drug products containing the pain reliever ibuprofen.

The products, which contain ibuprofen in combination with a variety of other active ingredients and are marketed for pain relief, are unapproved new drugs that require an approved new drug application in order to be legally marketed. Under its OTC drug monograph system, the FDA allows some OTC drugs to be marketed without first obtaining agency approval. These drugs must comply with applicable monographs, that is, regulations that set requirements for the drugs' labeling, formulations, and indications. Ibuprofen is not included in any OTC drug monograph. Companies wishing to market OTC drugs that do not meet the monograph requirements can submit and receive approval of a new drug application.

"These companies have an obligation to the public to demonstrate to the FDA that their products are safe and effective, and they have failed to do so," said Deborah M. Autor, director of the Office of Compliance at the FDA's Center for Drug Evaluation and Research.

Orally administered ibuprofen has been approved as a safe and effective treatment for pain and inflammation. There are no approved applications for topical ibuprofen products. Although the FDA has proposed to add orally administered ibuprofen to the applicable OTC monograph, it has never proposed that topical ibuprofen be added to any OTC monograph. Topical ibuprofen is often promoted as a "safer" alternative that can be used in place of oral ibuprofen because of certain side effects, such as stomach ulcers and cardiovascular effects that are associated with prolonged use of oral ibuprofen. However, these safety claims for topical ibuprofen have not been reviewed by the FDA, nor has the agency evaluated what side effects might be associated with such products.

The names of the products and manufacturers that received warning letters are:

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)

Legal Help

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Published on Aug-21-09


Posted by
Roxanna Grenfell
I have used IBU-REFIEF 12 FOR A LONG TIME AND AM 80 NOW WITH MORE ACES AND PAINS AND THIS IS THE BEST i HAVE EVER USED I can't buy it any place now and had to change to something else which will probley not do the job this is a great product when I would have leg cramps or joint pain or enything just rub a little of this on it and it would go right away. i sure hope I can find something else that will work as well. please give it back for sale.


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