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Label Changes for:

Solaraze (diclofenac sodium) gel 3%

December 2011

Changes have been made to the PRECAUTIONS sections of the safety label.

Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER) – December 2011



Drug Interactions

  • Specific interaction studies between Solaraze® Gel and other topical or oral agents were not performed.


Oral Nonsteroidal Anti-Inflammatory Drugs

  • Although low, there is systemic exposure to diclofenac following labeled use of Solaraze Gel. Therefore, concomitant administration of Solaraze® Gel with oral NSAIDS or aspirin may result in increased NSAID adverse effects.