Drug Catalog - Product Detail
CICLOPIROX OLAMINE CREAM 0.0077 30GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0297-35 | GLENMARK PHARMACEUTICALS | 30 | 0.77% | CREAM |
PACKAGE FILES
Generic Name
CICLOPIROX OLAMINE
Substance Name
CICLOPIROX OLAMINE
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA090273
Description
DESCRIPTION Ciclopirox olamine cream, USP, 0.77% is for topical use. Each gram of ciclopirox olamine cream, USP contains 7.70 mg of ciclopirox (as ciclopirox olamine USP) in a water miscible vanishing cream base consisting of benzyl alcohol (1%) as preservative, cetyl alcohol, lactic acid, light mineral oil, myristyl alcohol, octyldodecanol, polysorbate 60, purified water, sorbitan monostearate and stearyl alcohol. Ciclopirox olamine cream, USP contains a synthetic, broad-spectrum, antifungal agent ciclopirox (as ciclopirox olamine USP). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, 2 -aminoethanol salt. The CAS Registry Number is 41621-49-2. The chemical structure is: structure
How Supplied
HOW SUPPLIED Ciclopirox olamine cream USP, 0.77% is supplied in 15 grams (NDC 68462-297-17), 30 grams (NDC 68462-297-35) and 90 grams (NDC 68462-297-92) tubes.
Indications & Usage
INDICATIONS AND USAGE Ciclopirox olamine cream is indicated for the topical treatment of the following dermal infections: tinea pedis, tinea cruris, and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, Epidermophyton floccosum , and Microsporum canis ; candidiasis (moniliasis) due to Candida albicans ; and tinea (pityriasis) versicolor due to Malassezia furfur.
Dosage and Administration
DOSAGE AND ADMINISTRATION Gently massage ciclopirox olamine cream into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus and other symptoms usually occurs within the first week of treatment. If a patient shows no clinical improvement after four weeks of treatment with ciclopirox olamine cream, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.