Econazole (patient information)
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Abdurahman Khalil, M.D. [2]
PATIENT PACKAGE INSERT
Patient Information ECOZA (ee-ko-zah) (econazole nitrate) topical foam, 1% Important information: Ecoza topical foam is for use on skin only. Do not use Ecoza topical foam in your eyes or vagina.
What is Ecoza topical foam?
Ecoza topical foam is a prescription medicine used on the skin (topical) to treat athlete’s foot that is between the toes (interdigital tinea pedis) in people 12 years of age and older.
What should I tell my doctor before using Ecoza topical foam?
Before using Ecoza topical foam, tell your doctor about all of your medical conditions, including if you:
are pregnant or plan to become pregnant. It is not known if Ecoza topical foam will harm your unborn baby. are breastfeeding or plan to breastfeed. It is not known if Ecoza topical foam passes into your breast milk.
Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How should I use Ecoza topical foam?
See the detailed Instructions for Use for information about how to use Ecoza topical foam.
Use Ecoza topical foam exactly as your doctor tells you to use it. Apply Ecoza topical foam to the affected skin areas of your feet 1 time a day for 4 weeks. If Ecoza topical foam gets in or near your eyes, rinse them well with water. Wash your hands after you apply Ecoza topical foam.
What should I avoid while using Ecoza topical foam?
Ecoza topical foam is flammable. Avoid heat, flame and smoking while applying and right after you apply Ecoza topical foam to your skin.
What are the possible side effects of Ecoza topical foam?
Ecoza topical foam may cause skin reactions at the treatment site. Tell your doctor if you have any skin reactions on the areas of your skin treated with Ecoza topical foam.
These are not all the possible side effects of Ecoza topical foam.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
How should I store Ecoza topical foam?=
Store Ecoza topical foam at room temperature, between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze Ecoza topical foam. Do not store Ecoza topical foam in direct sunlight. Ecoza topical foam is flammable. Keep the Ecoza topical foam canister away from heat and temperatures above 120°F (49°C), even if the canister is empty. Do not puncture or burn the Ecoza topical foam canister.
Keep Ecoza topical foam and all medicines out of the reach of children.
General information about the safe and effective use of Ecoza topical foam
Medicines are sometimes prescribed for purposes other than those listed in a Patient Information leaflet. You can ask your doctor or pharmacist for information about Ecoza topical foam that is written for health professionals. Do not use Ecoza topical foam for a condition for which it was not prescribed. Do not give Ecoza topical foam to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in Ecoza topical foam?
Active ingredient: econazole nitrate
Inactive Ingredients: dimethicone, glycerin, polysorbate 20, povidone, propylene glycol, stearic acid, trolamine, purified water and butane as a propellant.
Manufactured in the USA for Quinnova Pharmaceuticals, LLC Jamison, PA 18929
For more information call Quinnova Pharmaceuticals, Inc. at 1-877-660-6263.
This Patient Information has been approved by the U.S. Food and Drug Administration. Issued:10/2013
Instructions for Use
Instructions for Use ECOZA (ee-ko-zah) (econazole nitrate) topical foam, 1%
Important information: Ecoza topical foam is for use on skin only. Do not use Ecoza topical foam in your eyes or vagina.
Parts of Ecoza topical foam Canister. (See Figure A)
How to apply Ecoza topical foam:
Step 1: Before you apply Ecoza topical foam, shake the Ecoza topical foam canister for about 5 seconds.
Step 2: Remove the cap and turn the Ecoza topical foam canister upside down over the palm of your hand.
Step 3: Press down firmly on the actuator until there is a small amount of foam about the size of a golf ball in the palm of your hand. (See Figures B and C)
Step 4: Use your finger-tips to scoop up small amounts of Ecoza topical foam and apply to the affected skin areas on your feet. Gently rub the foam into the skin. (See Figure D)
Step 5: You should apply Ecoza topical foam to your toes, to the spaces between your toes, and to the surrounding areas 1 time a day for 4 weeks or as prescribed by your doctor.
Step 6: Replace the cap.Wash your hands after applying Ecoza topical foam.
How should I store Ecoza topical foam?
Store Ecoza topical foam at room temperature, between 68°F to 77°F (20°C to 25°C). Do not refrigerate or freeze Ecoza topical foam. Do not store Ecoza topical foam in direct sunlight. Ecoza topical foam is flammable. Keep the Ecoza topical foam canister away from heat and temperatures above 120°F (49°C), even if the canister is empty. Do not puncture or burn the Ecoza topical foam canister.
Keep Ecoza topical foam and all medicines out of the reach of children.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Manufactured in the USA for Quinnova Pharmaceuticals, LLC Jamison, PA 18929
Issued: 10/2013
References
http://www.accessdata.fda.gov/drugsatfda_docs/label/2013/205175s000lbl.pdf