ECOZA (Page 2 of 3)

13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

Long-term animal studies to determine the carcinogenic potential of Ecoza topical foam have not been performed.

Oral administration of econazole nitrate in rats has been reported to produce prolonged gestation.

14 CLINICAL STUDIES

In two multi-center, randomized, double-blind, vehicle-controlled clinical trials a total of 505 subjects with interdigital tinea pedis were randomized 1:1 to Ecoza topical foam or vehicle; subjects applied the assigned medication once daily for 4 weeks. The severity of erythema, scaling, fissuring, maceration, vesiculation, and pruritus were graded using a 4-point scale (none, mild, moderate, severe). Subjects had KOH examination and fungal cultures taken to confirm eligibility. A total of 339 subjects with positive fungal cultures were evaluated for efficacy. Efficacy was evaluated on Day 43, 2 weeks post-treatment with treatment success being defined as complete cure (negative KOH and fungal culture and no evidence of clinical disease). The study population ranged in age from 12 to 71 years with 5 subjects less than 18 years of age at baseline. The subjects were 71% male and 51% Caucasian. Table 1 presents the efficacy results for each trial.

Table 1: Efficacy Results at Two Weeks Post-treatment (Day 43) Complete Cure, Effective Treatment and Mycological Cure
Trial 1 Trial 2
Ecoza topical foam, 1% N = 82 n(%) Foam Vehicle N = 83 n(%) Ecoza topical foam, 1% N = 91 n(%) Foam Vehicle N = 83 n(%)
*
Mycological cure and an absence of clinical signs and symptoms (erythema, scaling, fissuring, maceration, vesiculation, or pruritus).
Mycological cure and no or mild erythema and/or scaling with all other signs and symptoms absent.
Negative KOH and fungal culture.
Complete cure * 19 (23.2%) 2 (2.4%) 23 (25.3%) 4 (4.8%)
Effective treatment 40 (48.8%) 9 (10.8%) 44 (48.4%) 9 (10.8%)
Mycological cure 56 (68.3%) 13 (15.7%) 61 (67.0%) 15 (18.1%)

16 HOW SUPPLIED/ STORAGE AND HANDLING

Ecoza topical foam, 1% is white to off-white foam supplied in 10g (NDC 23710-100-10) and 70g (NDC 23710-100-75) 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.

17 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

PRODERM TECHNOLOGY ®

U.S, Patent 5,993,830

1007501-02

Issued: 07/2016

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 for Exeltis USA Dermatology, LLC Florham Park, NJ 07932

For more information call Exeltis USA, Inc. at 1-877-324-9349.

This Patient Information has been approved by the U.S. Food and Drug Administration. Issued:07/2016 1007501-02

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