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FDA sends warnings on topical ibuprofen

Jenny Decker RN's picture
topical ibuprofen

All medications have side effects. Finding alternative means to obtain the same effect a medication provides is an effective way to market and sale items that claim to have similar effects. Several manufacturers have produced and claimed their topical products produce the same effect as ibuprofen except that it is not hard on the stomach or cause cardiovascular side effects, like the oral ibuprofen has been found to do. This is because they have added ibuprofen to their gels.


The FDA sent out letters August 20th to several manufacturers who produce gels containing ibuprofen.

Manufacturers are claiming that the topical preparations are safer. However, the FDA states that these companies have failed to get the topical preparations approved. The claims of safety have not been approved by the FDA for safety and effectiveness for consumers. Claims are only claims at this time. The manufacturers must comply and seek approval if they are to continue making their products.

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The FDA sent letters of warning, expecting a response on how to fix the problem within 15 days. The FDA will take the companies to court to gain compliance. The FDA must approve the topical preparations before using the ibuprofen and making such claims on increased safety.

The companies and names of the products include the following:

o Emuprofen (Progressive Emu, Inc.)
o BioEntopic 15% Ibuprofen Crème (BioCentric Laboratories, Inc.)
o Ibunex Topical Ibuprofen (Core Products International, Inc.)
o LoPain AF 15% Ibuprofen Cream (Geromatrix Health Products)
o Profen HP (Ridge Medical Products)
o IbuPRO-10 Plus (Meditrend, Inc. dba Progena Professional Formulations)
o IBU-RELIEF 12 (Wonder Laboratories)

Source: FDA