Econazole Foam

Name: Econazole Foam

If OVERDOSE is suspected

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

Patient Counseling Information

See FDA-approved patient labeling (Patient Information)

The patient should be instructed as follows:

  • Inform patients that Econazole Nitrate Topical Foam, 1% is for topical use only. Econazole Nitrate Topical Foam, 1% is not intended for oral, intravaginal, or ophthalmic use.
  • Econazole Nitrate 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 Econazole Nitrate Topical Foam, 1%, use of the medication should be discontinued.

Distrubuted by
Xiromed, LLC
Florham Park, NJ 07932

U.S, Patent 5,993,830

Issued: 09/2016

PI100-00

Patient Information
Econazole Nitrate Topical Foam, 1 %
Important information: Econazole Nitrate Topical Foam, 1% is for use on skin only. Do not use Econazole Nitrate Topical Foam, 1% in your eyes or vagina.
What is Econazole Nitrate Topical Foam, 1%?
Econazole Nitrate Topical Foam, 1% 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 Econazole Nitrate Topical Foam, 1%?
Before using Econazole Nitrate Topical Foam, 1%, tell your doctor about all of your medical conditions, including if you:
  • are pregnant or plan to become pregnant. It is not known if Econazole Nitrate Topical Foam, 1% will harm your unborn baby.
  • are breastfeeding or plan to breastfeed. It is not known if Econazole Nitrate Topical Foam, 1% 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 Econazole Nitrate Topical Foam, 1%?
See the detailed Instructions for Use for information about how to use Econazole Nitrate Topical Foam, 1%.
  • Use Econazole Nitrate Topical Foam, 1% exactly as your doctor tells you to use it.
  • Apply Econazole Nitrate Topical Foam, 1% to the affected skin areas of your feet 1 time a day for 4 weeks.
  • If Econazole Nitrate Topical Foam, 1% gets in or near your eyes, rinse them well with water.
  • Wash your hands after you apply Econazole Nitrate Topical Foam, 1%.
What should I avoid while using Econazole Nitrate Topical Foam, 1%?
  • Econazole Nitrate Topical Foam, 1% is flammable. Avoid heat, flame and smoking while applying and right after you apply Econazole Nitrate Topical Foam, 1% to your skin.
What are the possible side effects of Econazole Nitrate Topical Foam, 1%?
Econazole Nitrate Topical Foam, 1% 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 Econazole Nitrate Topical Foam, 1%.
These are not all the possible side effects of Econazole Nitrate Topical Foam, 1%.
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 Econazole Nitrate Topical Foam, 1%?
  • Store Econazole Nitrate Topical Foam, 1% at room temperature, between 68°F to 77°F (20°C to 25°C).
  • Do not refrigerate or freeze Econazole Nitrate Topical Foam, 1%.
  • Do not store Econazole Nitrate Topical Foam, 1% in direct sunlight.
  • Econazole Nitrate Topical Foam, 1% is flammable. Keep the Econazole Nitrate Topical Foam, 1% canister away from heat and temperatures above 120°F (49°C), even if the canister is empty.
  • Do not puncture or burn the Econazole Nitrate Topical Foam, 1% canister.

Keep Econazole Nitrate Topical Foam, 1% and all medicines out of the reach of children.
General information about the safe and effective use of Econazole Nitrate Topical Foam, 1%
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 Econazole Nitrate Topical Foam, 1% that is written for health professionals. Do not use Econazole Nitrate Topical Foam, 1% for a condition for which it was not prescribed. Do not give Econazole Nitrate Topical Foam, 1% to other people, even if they have the same symptoms that you have. It may harm them.
What are the ingredients in Econazole Nitrate Topical Foam, 1%?
Active ingredient: econazole nitrate, USP
Inactive Ingredients: dimethicone, glycerin, polysorbate 20, povidone, propylene glycol, stearic acid, trolamine, purified water and butane as a propellant.
Distributed by Xiromed, LLC, Florham Park, NJ 07932
For more information call Xiromed, LLC. at 844-XIROMED (844-947-6633).
This Patient Information has been approved by the U.S. Food and Drug Administration.                    Issued: 09/2016
Share
(web3)