Ciclopirox Olamine
Ciclopirox Olamine is an FDA drug label for the active ingredient CICLOPIROX OLAMINE manufactured by Cosette Pharmaceuticals, Inc. administered by TOPICAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20221116.
- Generic name
- CICLOPIROX OLAMINE
- Manufacturer
- Cosette Pharmaceuticals, Inc.
- Product type
- HUMAN PRESCRIPTION DRUG
- Route
- TOPICAL
- Dosage form
- N/A
- NDC
- 0713-0638
- Application
- ANDA078463
- Label effective
- 20221116
Indications & Usage
INDICATIONS AND USAGE Ciclopirox Olamine Cream USP, 0.77% 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 & Administration
DOSAGE AND ADMINISTRATION Gently massage Ciclopirox Olamine Cream USP into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritis 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.
Contraindications
CONTRAINDICATIONS Ciclopirox Olamine Cream USP is contraindicated in individuals who have shown hypersensitivity to any of its components.
Warnings
WARNINGS Ciclopirox Olamine Cream USP is not for ophthalmic use. Keep out of reach of children.
Adverse Reactions
ADVERSE REACTIONS In all controlled clinical studies with 514 patients using Ciclopirox Olamine Cream and in 296 patients using the vehicle cream, the incidence of adverse reactions was low. This included pruritus at the site of application in one patient and worsening of the clinical signs and symptoms in another patient using ciclopirox cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream. To report SUSPECTED ADVERSE REACTIONS, contact Cosette Pharmaceuticals, Inc.at 1-800-922-1038 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .