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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 Econazole Nitrate Topical Foam, 1% 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 During clinical trials with Econazole Nitrate Topical Foam, 1%, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Econazole Nitrate Topical Foam, 1% and vehicle arms. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Xiromed, LLC. at 844-XIROMED (844-947-6633) 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 were exposed to Econazole Nitrate Topical Foam, 1% or vehicle (246 subjects were exposed to Econazole Nitrate Topical Foam, 1% and 249 were exposed to vehicle). Subjects with interdigital tinea pedis applied foam or vehicle once daily for approximately 28 days. During clinical trials with Econazole Nitrate Topical Foam, 1%, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Econazole Nitrate Topical Foam, 1% and vehicle arms.