Econazole Nitrate Cream, 1%

Econazole nitrate cream contains the antifungal agent, econazole nitrate USP 1%, in a water-miscible base consisting of benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol-7 stearate, and purified water. The white to off-white homogenous cream is for topical use only.

Chemically, econazole nitrate is (±)-1-[2,4-Dichloro-β-[(p-chlorobenzyl)oxy]phenethyl]-imidazole mononitrate. Its structure is as follows:

  Chemical Structure

After topical application to the skin of normal subjects, systemic absorption of econazole nitrate is extremely low. Although most of the applied drug remains on the skin surface, drug concentrations were found in the stratum corneum, which, by far, exceeded the minimum inhibitory concentration for dermatophytes. Inhibitory concentrations were achieved in the epidermis and as deep as the middle region of the dermis. Less than 1% of the applied dose was recovered in the urine and feces.

Microbiology: Econazole nitrate has been shown to be active against most strains of the following microorganisms, both in vitro and in clinical infections as described in the INDICATIONS AND USAGE section.

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Dermatophytes                                                                                                       Yeasts

Epidermophyton floccosum       Trichophyton mentagrophytes                  Candida albicans

Microsporum audouini              Trichophyton rubrum                               Malassezia furfur

Microsporum canis                    Trichophyton tonsurans

Microsporum gypseum

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Econazole nitrate exhibits broad-spectrum antifungal activity against the following organisms in vitro, but the clinical significance of these data is unknown.

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Dermatophytes                                                                                        Yeasts

Trichophyton verrucosum                                                              Candida guillermondii

                                                                                                       Candida parapsilosis

                                                                                                        Candida tropicalis

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Econazole nitrate cream is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor. 

Econazole nitrate cream is contraindicated in individuals who have shown hypersensitivity to any of its ingredients. 

Econazole nitrate cream is not for ophthalmic use. 

During clinical trials, approximately 3% of patients treated with econazole nitrate cream, 1% reported side effects thought possibly to be due to the drug, consisting mainly of burning, itching, stinging, and erythema. One case of pruritic rash has also been reported. 

Overdosage of econazole nitrate in humans has not been reported to date. In mice, rats, guinea pigs and dogs, the oral LD 50 values were found to be 462, 668, 272, and > 160 mg/kg, respectively. 

Sufficient econazole nitrate cream should be applied to cover affected areas once daily in patients with tinea pedis, tinea cruris, tinea corporis, and tinea versicolor, and twice daily (morning and evening) in patients with cutaneous candidiasis.

Early relief of symptoms is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, candidal infections and tinea cruris and corporis should be treated for two weeks and tinea pedis for one month in order to reduce the possibility of recurrence. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment. 

Econazole Nitrate Cream, 1% contains econazole nitrate USP. The white to off-white homogenous cream is available as follows:

15 g aluminum tube            NDC 59651-945-14

30 g aluminum tube            NDC 59651-945-30

85 g aluminum tube            NDC 59651-945-85

Store econazole nitrate cream below 30°C (86°F).

To report SUSPECTED ADVERSE REACTIONS, contact Aurobindo Pharma USA, Inc. at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch for voluntary reporting of adverse reactions.

Distributed by:
Aurobindo Pharma USA, Inc.
279 Princeton-Hightstown Road
East Windsor, NJ 08520

Manufactured by:
Aurobindo Pharma Limited
Hyderabad-500 032, India

Revised: 04/2026

NDC 59651-945-14

Rx only

Econazole Nitrate Cream
1%

For Topical Use Only. Not for Ophthalmic Use.

AUROBINDO                                   Net Wt. 15 g

 PACKAGE LABEL.PRINCIPAL DISPLAY PANEL-15 g (Tube Label)

NDC 59651-945-14

Rx only

Econazole Nitrate Cream
1%

For Topical Use Only. Not for Ophthalmic Use.

AUROBINDO                                   Net Wt. 15 g

   PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 15 g (Tube Carton)