Drug Catalog - Product Detail
ECONAZOLE NITRATE CREAM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 47781-0543-86 | ALVOGEN | 85 | 1% | CREAM |
Generic Name
Substance Name
Product Type
Route
Application Number
Description
DESCRIPTION Econazole Nitrate Cream contains the antifungal agent, econazole nitrate 1%, in a water-miscible base consisting of pegoxol 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:
How Supplied
HOW SUPPLIED Econazole Nitrate Cream, 1% is supplied in tubes of 15 grams (NDC 47781-543-72), 30 grams (NDC 47781-543-73), and 85 grams (NDC 47781-543-86). Store Econazole Nitrate Cream below 86°F.
Indications & Usage
INDICATIONS AND USAGE 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.
Dosage and Administration
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.