ciclopirox olamine

FDA Drug Profile — Ciclopirox Olamine

Drug Details

Generic Name
ciclopirox olamine
Brand Names
Ciclopirox Olamine
Application Number
ANDA076790
Sponsor
Sun Pharmaceutical Industries, Inc.
NDC Codes
1
Dosage Forms
CREAM
Routes
TOPICAL
Active Ingredients
CICLOPIROX OLAMINE

Indications and Usage

INDICATIONS AND USAGE Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) 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; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur .

Warnings

WARNINGS General - Ciclopirox Olamine Topical Suspension USP, 0.77% (w/w) (Lotion) is not for ophthalmic use. Keep out of reach of children.