Label: monistat-derm- Miconazole nitrate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 0062-5434-01, 0062-5434-02, 0062-5434-03 - Packager: Ortho Dermatological
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated April 17, 2007
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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.
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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.
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INGREDIENTS AND APPEARANCE
MONISTAT-DERM
miconazole nitrate creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0062-5434 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole nitrate (UNII: VW4H1CYW1K) (Miconazole nitrate - UNII:VW4H1CYW1K) 20 mg in 1 g Inactive Ingredients Ingredient Name Strength Pegoxol 7 stearate () Peglicol 5 oleate () Mineral oil () Benzioc acid () Butylated hydroxyanisole () Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0062-5434-02 15 g in 1 TUBE 2 NDC:0062-5434-01 28 g in 1 TUBE 3 NDC:0062-5434-03 85 g in 1 TUBE Labeler - Ortho Dermatological