Ecoza Foam

Name: Ecoza Foam

Adverse Reactions

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. 

Ecoza Foam Description

Ecoza (econazole nitrate) topical foam, 1% contains the azole antifungal agent, econazole nitrate in an oil-in-water emulsion base consisting of the following inactive ingredients: dimethicone, glycerin, polysorbate 20, povidone, propylene glycol, stearic acid, trolamine, purified water and butane as a propellant. Each gram of Ecoza topical foam, 1% contains 10 mg of econazole nitrate, USP, in a white to off-white foam. Ecoza topical foam, 1% is alcohol (ethanol)-free and for topical use only.

Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl)methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Econazole nitrate has the molecular formula C18H15Cl3N2O.HNO3 and a molecular weight of 444.70. Its molecular structure is as follows:

How supplied/ storage and handling

Ecoza topical foam, 1% is white to off-white foam supplied in 70 g (NDC 23710-100-70) aluminum pressurized canister.

Store at controlled room temperature 20°C to 25°C (68°F to 77°F) with excursions permitted between 15°C and 30°C (59°F and 86°F). Do not refrigerate or freeze.

Ecoza topical foam 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.

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
Exeltis USA Dermatology, LLC
Florham Park, NJ 07932

U.S, Patent 5,993,830

Issued: 07/2016

1007001-01

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, USP
Inactive Ingredients: dimethicone, glycerin, polysorbate 20, povidone, propylene glycol, stearic acid, trolamine, purified water and butane as a propellant.
Manufactured in the USA for Exeltis USA Dermatology, LLC, Florham Park, NJ 07932
For more information call Exeltis USA Dermatology, LLC. at 1-877- 324-9349.
This Patient Information has been approved by the U.S. Food and Drug Administration.                    Issued: 07/2016

PRINCIPAL DISPLAY PANEL - 70 g Canister Carton

NDC 23710-100-70

ecoza™

(econazole nitrate)
topical foam, 1%

For Topical Use Only
Not for ophthalmic, oral
or intravaginal use.

Keep Out of Reach of Children

Rx Only
Net Wt 70g

Exeltis
Rethinking Healthcare

ECOZA 
econazole nitrate aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:23710-100
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ECONAZOLE NITRATE (ECONAZOLE) ECONAZOLE NITRATE 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
DIMETHICONE  
GLYCERIN  
POLYSORBATE 20  
POVIDONE K29/32  
PROPYLENE GLYCOL  
STEARIC ACID  
TROLAMINE  
WATER  
BUTANE  
Product Characteristics
Color WHITE (white to off-white) Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:23710-100-70 1 CAN in 1 CARTON
1 70 g in 1 CAN
2 NDC:23710-100-75 1 CAN in 1 CARTON
2 70 g in 1 CAN
3 NDC:23710-100-10 1 CAN in 1 CARTON
3 10 g in 1 CAN
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA205175 10/25/2013
Labeler - Exeltis USA Dermatology, LLC (078715346)
Registrant - AmDerma Pharmaceuticals, LLC (963768994)
Establishment
Name Address ID/FEI Operations
DPT Laboratories, Ltd. 832224526 ANALYSIS(23710-100), LABEL(23710-100), MANUFACTURE(23710-100), PACK(23710-100)
Revised: 07/2016   Exeltis USA Dermatology, LLC
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