Econazole patient counseling information

Econazole
ECOZA®,ECONAZOLE NITRATE® FDA Package Insert
Description
Clinical Pharmacology
Microbiology
Indications and Usage
Contraindications
Warnings and Precautions
Adverse Reactions
Clinical Studies
Dosage and Administration
Patient Counseling Information
How Supplied
Labels and Packages

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]

PATIENT COUNSELING INFORMATION

See FDA-approved patient labeling (Patient Information)

The patient should be instructed as follows:

Inform patients that Ecoza (econazole nitrate) topical foam, 1% is for topical use only. Ecoza (econazole nitrate) topical foam, 1% is not intended for oral, intravaginal, or ophthalmic use. Ecoza topical foam, 1% is flammable; avoid heat, flame, and smoking during and immediately following application. If a reaction suggesting sensitivity or chemical irritation develops with the use of Ecoza topical foam, 1%, use of the medication should be discontinued.

Manufactured in the USA for Quinnova Pharmaceuticals, LLC Jamison, PA 18929

References

http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205175s000lbl.pdf