Ciclopirox Olamine
Generic: CICLOPIROX OLAMINE
Basic Information
Manufacturer
Cosette Pharmaceuticals, Inc.
Product Type
HUMAN PRESCRIPTION DRUG
Route of Administration
TOPICAL
FDA Set ID
5c585aa5-7d2d-e798-c0bd-d602574d643c
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 .
Warnings
WARNINGS Ciclopirox Olamine Cream USP 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 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 .
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 .