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warnings and cautions
5 WARNINGS AND PRECAUTIONS Contents are flammable. Instruct the patient to avoid heat, flame, and/or smoking during and immediately following application. ( 5.1 ) 5.1 Flammability Ecoza is flammable. Avoid heat, flame, and smoking during and immediately following application. Contents under pressure. Do not puncture and/or incinerate the containers. Do not expose containers to heat and/or store at temperatures above 120°F (49°C) even when empty. Do not store in direct sunlight.
6. ADVERSE REACTIONS The most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Ecoza and vehicle arms. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Glenmark Therapeutics Inc., at 1-888-721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. In two double-blind, vehicle-controlled clinical trials, 495 subjects with interdigital tinea pedis applied Ecoza or vehicle once daily for approximately 28 days (246 subjects were exposed to Ecoza and 249 were exposed to vehicle). During clinical trials with Ecoza, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Ecoza and vehicle arms.