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ECONAZOLE NITRATE CREAM, 1%

Rx only

FOR TOPICAL USE ONLY

NOT FOR OPHTHALMIC USE

DESCRIPTION

Econazole Nitrate Cream, 1% contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of pegoxyl 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole, and purified water. The white to off-white soft cream is for topical use only.

Chemically, econazole nitrate is 1-[2-{(4-chloro-phenyl)methoxy}-2-(2,4-dichlorophenyl)ethyl]-1H-imidazole mononitrate. Its structure is as follows:

CLINICAL PHARMACOLOGY

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.

INDICATIONS AND USAGE

Econazole Nitrate Cream, 1% is indicated for topical application in the treatment of tinea pedis, tinea cruris, and tinea corporis caused byTrichophyton rubrum, Trichophyton mentagrophytes, Trichophyton tonsurans, Microsporum canis, Microsporum audouini, Microsporum gypseum, andEpidermophyton floccosum, in the treatment of cutaneous candidiasis, and in the treatment of tinea versicolor.

CONTRAINDICATIONS

Econazole Nitrate Cream, 1% is contraindicated in individuals who have shown hypersensitivity to any of its ingredients.

WARNINGS

Econazole Nitrate Cream, 1% is not for ophthalmic use.

PRECAUTIONS

ADVERSE REACTIONS

During clinical trials, approximately 3% of patients treated with econazole nitrate 1% cream 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

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.

DOSAGE AND ADMINISTRATION

Sufficient Econazole Nitrate Cream 1% 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.

HOW SUPPLIED

Econazole Nitrate Cream 1% is supplied as follows:

NDC 0168-0312-15 15 gram tube

NDC 0168-0312-30 30 gram tube

NDC 0168-0312-85 85 gram tube

Store Econazole Nitrate 1% Cream below 86°F (30°C).

E. FOUGERA & CO.
a division of Altana Inc.
MELVILLE, NEW YORK 11747

I2312
R10/01
#20

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