Monistat Derm

Name: Monistat Derm

Monistat Derm Overview

Monistat Derm is a brand name medication included in the following groups of medications: Sympathomimetics used as decongestants, Sympathomimetics, combinations excl. corticosteroids, Sympathomimetics, plain. For more information about Monistat Derm see its generic Oxymetazoline

Monistat Derm Drug Class

Monistat Derm is part of the drug classes:

  • Sympathomimetics used as decongestants

  • Sympathomimetics, combinations excl. corticosteroids

  • Sympathomimetics, plain

Monistat-Derm (miconazole nitrate 2%) Cream

For Topical Use Only

Description

Monistat-Derm (miconazole nitrate 2%) Cream contains miconazole nitrate* 2%, formulated into a water-miscible base consisting of pegoxol 7 stearate, peglicol 5 oleate, mineral oil, benzoic acid, butylated hydroxyanisole and purified water.

*Chemical name: 1-[2,4-dicholoro-B-{(2,5-dichlorobenzyl) oxy} phenethyl] imidazole mononitrate.

Actions

Miconazole nitrate is a synthetic antifungal agent which inhibits the growth of the common dermatophytes, Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum, the yeast-like fungus, Candida albicans, and the organism responsible for tinea versicolor (Malassezia furfur).

Indications

For topical application in the treatment of tinea pedis (athlete's foot), tinea cruris, and tinea corporis caused by Trichophyton rubrum, Trichophyton mentagrophytes, and Epidermophyton floccosum, in the treatment of cutaneous candidiasis (moniliasis), and in the treatment of tinea versicolor.

Contraindications

Monistat-Derm (miconazole nitrate 2%) Cream has no known contraindications.

Dosage and Administration

Sufficient Monistat-Derm Cream should be applied to cover affected areas twice daily (morning and evening) in patients with tinea pedis, tinea cruris, tinea corporis, and cutaneous candidiasis, and once daily in patients with tinea versicolor. If Monistat-Derm Cream is used in intertriginous areas, it should be applied sparingly and smoothed in well to avoid maceration effects.

Early relief of symptoms (2 to 3 days) is experienced by the majority of patients and clinical improvement may be seen fairly soon after treatment is begun; however, Candida 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 a month of treatment, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.

How Supplied

Monistat-Derm (miconazole nitrate 2%) Cream containing miconazole nitrate at 2% strength is supplied in 15g, 1 oz. and 3 oz. tubes.

Ortho Dermatological
Division of Ortho-McNeil
Pharmaceutical, Inc.
Skillman, New Jersey 08558

© OMP 2001
Printed in U.S.A.
Revised February 2001
631-10-471-3

Monistat-Derm 
miconazole nitrate cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0062-5434
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Miconazole nitrate (Miconazole nitrate) Miconazole nitrate 20 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Pegoxol 7 stearate  
Peglicol 5 oleate  
Mineral oil  
Benzioc acid  
Butylated hydroxyanisole  
Water  
Packaging
# Item Code Package Description
1 NDC:0062-5434-02 15 g (15 GRAM) in 1 TUBE
2 NDC:0062-5434-01 28 g (28 GRAM) in 1 TUBE
3 NDC:0062-5434-03 85 g (85 GRAM) in 1 TUBE
Labeler - Ortho Dermatological
Revised: 04/2007   Ortho Dermatological
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