Complete adverse effect profile including incidence rates and management
Important Safety Information
This is not a complete list of all possible side effects. Contact your healthcare provider if you experience any unexpected symptoms. For serious or life-threatening side effects, seek emergency medical attention immediately.
6 ADVERSE REACTIONS During clinical trials with Ecoza topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Ecoza and vehicle arms.
( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Resilia Pharmaceuticals at 1-888-998-0770 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 Ecoza topical foam or vehicle (246 subjects were exposed to Ecoza 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 Ecoza topical foam, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Ecoza and vehicle arms.
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 topical foam is flammable.
Avoid heat, flame, and smoking during and immediately following application.
Contents under pressure.
Like all medications, Ecoza can cause side effects. However, not everyone who takes this medication will experience them. Many side effects are dose-dependent and may improve as your body adjusts to the medication. Others may require dose adjustment or medical attention.
Contact your healthcare provider promptly if you experience:
Seek immediate emergency medical care if you experience signs of: