Drug Catalog - Product Detail
KETOCONAZOLE CREAM 2% 60GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 71085-0008-60 | IPG PHARMACEUTICALS | 60 | 2% | NA |
PACKAGE FILES
Generic Name
KETOCONAZOLE
Substance Name
KETOCONAZOLE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA075638
Description
DESCRIPTION Ketoconazole cream, 2% contains the broad-spectrum synthetic antifungal agent, ketoconazole 2%, formulated in an aqueous cream vehicle consisting of butylated hydroxyanisole (BHA), cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol. Ketoconazole is cis -1-acetyl-4-[4-[[2-(2,4-dichlorophenyl)-2-(1 H -imidazol-1-ylmethyl)-1,3-dioxolan-4-yl]methoxy]phenyl] piperazine and has the following structural formula: Molecular Formula: C 26 H 28 CI 2 N 4 O 4 Molecular Weight: 531.43 Chemical Structure
How Supplied
HOW SUPPLIED Ketoconazole cream, 2% is supplied in 60 g (NDC 71085-008-60) tubes. Store at 20˚ to 25°C (68˚ to 77°F) [see USP Controlled Room Temperature].
Indications & Usage
INDICATIONS AND USAGE Ketoconazole cream, 2% is indicated for the topical treatment of tinea corporis, tinea cruris and tinea pedis caused by Trichophyton rubrum, T. mentagrophytes and Epidermophyton floccosum; in the treatment of tinea (pityriasis) versicolor caused by Malassezia furfur (Pityrosporum orbiculare); in the treatment of cutaneous candidiasis caused by Candida spp. and in the treatment of seborrheic dermatitis.
Dosage and Administration
DOSAGE AND ADMINISTRATION Cutaneous candidiasis, tinea corporis, tinea cruris, tinea pedis, and tinea (pityriasis) versicolor It is recommended that ketoconazole cream, 2% be applied once daily to cover the affected and immediate surrounding area. 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 in order to reduce the possibility of recurrence. Patients with tinea versicolor usually require two weeks of treatment. Patients with tinea pedis require six weeks of treatment. Seborrheic dermatitis Ketoconazole cream, 2% should be applied to the affected area twice daily for four weeks or until clinical clearing. If a patient shows no clinical improvement after the treatment period, the diagnosis should be redetermined.