(See WARNINGS and PRECAUTIONS sections.)

In double-blind, vehicle-controlled studies involving 179 patients who applied RENOVA to their face, adverse reactions associated with the use of RENOVA were limited primarily to the skin. During these trials, 4% of patients had to discontinue use of RENOVA because of adverse reactions. These discontinuations were due to skin irritation or related cutaneous adverse reactions.

Local reactions such as peeling, dry skin, burning, stinging, erythema, and pruritus were reported by almost all subjects during therapy with RENOVA. These signs and symptoms were usually of mild to moderate severity and generally occurred early in therapy. In most patients the dryness, peeling, and redness recurred after an initial (24 week) decline.