Ciclopirox Olamine
Generic: CICLOPIROX OLAMINE
Basic Information
Manufacturer
Bryant Ranch Prepack
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
aa326ade-ff55-4355-b6c7-205d6d88d0a3
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.
Warnings
WARNINGS Ciclopirox olamine cream is not for ophthalmic use.
Keep out of reach of children.
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 olamine cream and burning in one patient and worsening of the clinical signs and symptoms in another patient using the vehicle cream.
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.