ECOZA- econazole nitrate aerosol, foam

ECOZA by

Drug Labeling and Warnings

ECOZA by is a Prescription medication manufactured, distributed, or labeled by Glenmark Therapeutics Inc.,USA, DPT Laboratories, Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

  • 1 INDICATIONS AND USAGE

    Ecoza isindicated for the treatment of interdigital tinea pedis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum in patients 12 years of age and older.

  • 2 DOSAGE AND ADMINISTRATION

    Ecoza is for topical use only. It is not for oral, ophthalmic, or intravaginal use.

    Ecoza should be applied to cover affected areas once daily for 4 weeks.

  • 3 DOSAGE FORMS AND STRENGTHS

    Topical foam, 1%. Each gram contains 10 mg of econazole nitrate in a white to off-white foam.

  • 4 CONTRAINDICATIONS

    None.

  • 5 WARNINGS AND PRECAUTIONS

    5.1 Flammability

    Ecoza 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.

  • 6. ADVERSE REACTIONS

    6.1 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 with interdigital tinea pedis applied Ecoza or vehicle once daily for approximately 28 days (246 subjects were exposed to Ecoza and 249 were exposed to vehicle). During clinical trials with Ecoza, the most common adverse reactions were application site reactions which occurred in less than 1% of subjects in both the Ecoza and vehicle arms.

  • 7 DRUG INTERACTIONS

    7.1 Warfarin

    Concomitant administration of econazole and warfarin has resulted in enhancement of anticoagulant effect. Most cases reported product application with use under occlusion, genital application, or application to a large body surface area which may increase the systemic absorption of econazole nitrate. Monitoring of International Normalized Ratio (INR) and/or prothrombin time may be indicated especially for patients who apply econazole to large body surface areas, in the genital area, or under occlusion.

  • 8 USE IN SPECIFIC POPULATIONS

    8.1 Pregnancy

    Risk Summary

    There are no available data on Ecoza use in pregnant women to evaluate a drug-associated risk of major birth defects, miscarriage, or adverse maternal or fetal outcomes.

    In animal reproduction studies, econazole nitrate did not cause malformation in mice, rabbits and/or rats at oral doses 80 or 40 times the human dermal dose (see Data).

    All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively.

    Data

    Animal Data

    Econazole nitrate did not cause malformation in mice, rabbits and/or rats. Fetotoxic or embryotoxic effects were observed in oral fertility studies in rats receiving 10 to 40 times the human dermal dose. Similar effects were observed in embryofetal and pre- and postnatal developmental studies in mice, rabbits and/or rats receiving oral doses 80 or 40 times the human dermal dose.

    8.2 Lactation

    Risk Summary

    There is no information available on the presence of econazole nitrate in human milk, the effects of the drug on the breastfed infant, or the effects of the drug on milk production after topical application of Ecoza to women who are breastfeeding. It is not known whether econazole nitrate is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when econazole nitrate is administered to a nursing woman. Following oral administration of econazole nitrate to lactating rats, econazole and/or metabolites were excreted in milk and were found in nursing pups.

    The lack of clinical data during lactation precludes a clear determination of the risk Ecoza to an infant during lactation. Therefore, the developmental and health benefits of breastfeeding should be considered along with the mother’s clinical need for Ecoza and any potential adverse effects on the breastfed infant from Ecoza or from the underlying maternal condition.

    8.4 Pediatric Use

    Of the 173 subjects treated with Ecoza in the clinical trials, 2 subjects were 12-17 years old. In a pediatric maximal use trial, Ecoza was applied once daily to eighteen subjects aged 12 to 17 years with interdigital tinea pedis for 28 days [see Clinical Pharmacology (12.3)]. The safety findings for subjects 12 to 17 years were similar to those in adult population.

    8.5 Geriatric Use

    Of the 173 subjects treated with Ecoza in the adult clinical trials, 6 subjects were 65 years or older. No overall differences in safety or effectiveness were observed between these subjects and younger subjects.

  • 11 DESCRIPTION

    Ecoza (econazole nitrate) topical foam, 1% contains the azole antifungal agent, econazole nitrate in an oil-in-water emulsion base. 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:

    structure

    Ecoza (econazole nitrate) topical foam contains the following inactive ingredients: dimethicone, glycerin, polysorbate 20, povidone, propylene glycol, stearic acid, trolamine, purified water and butane as a propellant.

  • 12 CLINICAL PHARMACOLOGY

    12.1 Mechanism of Action

    Ecoza is an azole antifungal [see Clinical Pharmacology (12.4)].

    12.2 Pharmacodynamics

    The pharmacodynamics of Ecoza have not been established.

    12.3 Pharmacokinetics

    The systemic absorption of Ecoza following topical application was studied in one clinical trial in adults and one clinical study in pediatric subjects.

    In the adult trial, 19 subjects (male and female) with tinea pedis applied Ecoza once daily for 29 days. Subjects applied a mean daily amount of 2.4 g of Ecoza to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 29 at pre-dose and 1, 2, 4, 6, 8, and 12 hours after application. Results (mean ± SD) showed the time to reach peak plasma concentrations (Tmax) was 6.8 ± 5.1 h with maximum concentration (Cmax) of 417 ± 218 pg/mL. The area under the concentration time curve for the first 12 hours post application on Day 29 (AUC(0-12)) was 3440 ± 1920 pg-h/ml.

    In the pediatric trial, 18 subjects (male and female ages 12 - 17) with interdigital tinea pedis and positive fungal cultures were treated with Ecoza once daily for 4 weeks. Subjects applied a mean daily amount of 3.2 g of Ecoza to soles, toes, interdigital spaces and tops of both feet up to the ankles. Blood samples were obtained on Day 28 at pre-dose and 7 h and 11 h post-dose. The mean ± SD econazole plasma concentration was 397 ± 289, 534 ± 745 and 575 ± 638 pg/mL at pre-dose and 7 h and 11 h post-dose, respectively.

    Drug Interaction Studies

    Ecoza is not expected to inhibit CYP1A2, 2B6, 2C8, 2C9, 2C19, 2D6, and 3A4, or induce CYP1A2, 2B6, and 3A4.

    12.4 Microbiology

    Mechanism of Action

    Econazole nitrate, an azole antifungal agent, inhibits fungal cytochrome P-450-mediated 14 alpha‑ lanosterol demethylase enzyme. This enzyme functions to convert lanosterol to ergosterol. The accumulation of 14 alpha-methyl sterols correlates with the subsequent loss of ergosterol in the fungal cell wall and may be responsible for the fungistatic activity of econazole. Mammalian cell demethylation is less sensitive to econazole inhibition.

    Activity in vitro and in clinical infections

    Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections [see Indications and Usage (1)]

    Trichophyton rubrum

    Epidermophyton floccosum

    Trichophyton mentagrophytes

  • 13 NONCLINICAL TOXICOLOGY

    13.1 Carcinogenesis, Mutagenesis, Impairment of Fertility

    Long-term animal studies to determine the carcinogenic potential of Ecoza 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 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 3 subjects less than 18 years of age at baseline. The subjects were 71% male and 52% 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
    Study 1Study 2
    Ecoza
    N = 82
    n(%)    		Foam Vehicle
    N = 83
    n(%)    		Ecoza
    N = 91
    n(%)    		Foam Vehicle
    N = 83
    n(%)

    Complete curea

    19 (23.2%)

    2 (2.4%)

    23 (25.3%)

    4 (4.8%)

    Effective treatmentb

    40 (48.8%)

    9 (10.8%)

    44 (48.4%)

    9 (10.8%)

    Mycological curec

    56 (68.3%)

    13 (15.7%)

    61 (67.0%)

    15 (18.1%)
    •   a Mycological cure and an absence of clinical signs and symptoms (erythema, scaling, fissuring, maceration, vesiculation, or pruritus).
    •   b Mycological cure and no or mild erythema and/or scaling with all other signs and symptoms absent.
    •   c Negative KOH and fungal culture.
  • 16 HOW SUPPLIED/ STORAGE AND HANDLING

    Ecoza topical foam, 1% is white to off-white foam supplied in 70 g (NDC: 72657-0200-70) 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.

  • 17 PATIENT COUNSELING INFORMATION

    See FDA-approved patient labeling (Patient Information)

    The patient should be instructed as follows:

    • Inform patients that Ecoza is for topical use only. Ecoza is not intended for oral, intravaginal, or ophthalmic use.
    • Ecoza 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 use of the medication should be discontinued.
  • SPL UNCLASSIFIED SECTION

    Marketed by:

    Glenmark Therapeutics Inc., USA

    Mahwah, NJ 07430

    proderm-logo
    glenmark-logo
  • 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:
    • 1. are pregnant or plan to become pregnant. It is not known if Ecoza topical foam will harm your unborn baby.
    • 2. 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.
    • 1. Use Ecoza topical foam exactly as your doctor tells you to use it.
    • 2. Apply Ecoza topical foam to the affected skin areas of your feet 1 time a day for 4 weeks.
    • 3. If Ecoza topical foam gets in or near your eyes, rinse them well with water.
    • 4. 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.

    Marketed by:

    Glenmark Therapeutics Inc.

    Mahwah, NJ 07430

    For more information call Glenmark Therapeutics Inc., USA at 1-888-721-7115.

    This Patient Information has been approved by the U.S. Food and Drug Administration.

    Issued: 03/2019

  • 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)

    parts-figure-a
                                               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)

    parts-figure-bparts-figure-c

    Figure B

    Figure 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)

    parts-figure-ds
    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.

    Marketed by

    Glenmark Therapeutics Inc.

    Mahwah, NJ 07430

    Issued: 03/2019

  • PRINCIPAL DISPLAY PANEL - 70 g Can Label

    NDC: 72657-200-70

    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

    ecoza-label
  • PRINCIPAL DISPLAY PANEL - 70 g Canister Carton

    NDC: 72657-200-70

    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

    ecoza-carton
  • INGREDIENTS AND APPEARANCE
    ECOZA 
    econazole nitrate aerosol, foam
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 72657-200
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ECONAZOLE NITRATE (UNII: H438WYN10E) (ECONAZOLE - UNII:6Z1Y2V4A7M) ECONAZOLE NITRATE10 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    POVIDONE K30 (UNII: U725QWY32X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    BUTANE (UNII: 6LV4FOR43R)  
    Product Characteristics
    ColorWHITE (white to off-white) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC: 72657-200-701 in 1 CARTON10/25/2013
    170 g in 1 CAN; Type 0: Not a Combination Product
    2NDC: 72657-200-991 in 1 CARTON10/25/2013
    210 g in 1 CAN; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20517510/25/2013
    Labeler - Glenmark Therapeutics Inc.,USA (969085666)
    Registrant - Glenmark Therapeutics Inc.,USA (969085666)
    Establishment
    NameAddressID/FEIBusiness Operations
    DPT Laboratories, Ltd.832224526ANALYSIS(72657-200) , LABEL(72657-200) , MANUFACTURE(72657-200) , PACK(72657-200)

    • Trademark Results [ECOZA]

    Mark Image

    Registration | Serial
    Company
    Trademark
    Application Date
    ECOZA
    ECOZA
    97432935 not registered Live/Pending
    Resilia Pharmaceuticals, Inc.
    2022-05-27
    ECOZA
    ECOZA
    87019005 5162832 Live/Registered
    GLENMARK THERAPEUTICS INC., USA
    2016-04-29
    ECOZA
    ECOZA
    86092555 4822727 Live/Registered
    GLENMARK THERAPEUTICS INC., USA
    2013-10-16
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