Indications
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.
Contraindications
Ciclopirox olamine cream is contraindicated in individuals who have shown hypersensitivity to any of its components.
Warnings and precautions
Ciclopirox olamine cream is not for ophthalmic use. Keep out of reach of children.
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 olamine cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.
Composition
- Active ingredients
- CICLOPIROX 0.77%
Strengths and forms
The FDA lists each strength of a product separately; these pages share one label.
At a glance
- Brand name
- Ciclopirox
- Route
- Topical
- Dosage form
- Cream
- Applicant
- Padagis Israel
- Status
- Prescription
- FDA approval
- 3 Mar 2006
- Application
- ANDA077364-001