RVP

Drug Catalog - Product Detail

CICLOPIROX TOPICAL 0.0077 SUSP 30ML

NDC Mfr Size Str Form
69315-0309-30 LEADING PHARMA 30 0.77% NA
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Description
DESCRIPTION Ciclopirox Topical Suspension, USP 0.77% is for topical use. Each ml of Ciclopirox Topical Suspension, USP 0.77% contains 7.70 mg of ciclopirox (as ciclopirox olamine) in a water miscible suspension base consisting of purified water USP, cocamide DEA, octyldodecanol NF, mineral oil USP, stearyl alcohol NF, cetyl alcohol NF, polysorbate 60 NF, myristyl alcohol NF, lactic acid USP, sorbitan monostearate NF, and benzyl alcohol NF (1%) as preservative. Ciclopirox Topical Suspension, USP 0.77% contains a synthetic, broad spectrum, antifungal agent ciclopirox (as ciclopirox olamine). The chemical name is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )-pyridone, 2-aminoethanol salt. The CAS Registry Number is 41621-49-2. Ciclopirox Topical Suspension, USP 0.77% has a pH of 7. The chemical structure is: image description
How Supplied
HOW SUPPLIED Ciclopirox Topical Suspension, USP 0.77% is supplied in 30 mL bottles (NDC 69315-309-30) 60 mL bottles (NDC 69315-309-60) Bottle space provided to allow for vigorous shaking before each use. Store between 5º - 25ºC (41º - 77ºF). To report SUSPECTED ADVERSE REACTIONS, call 1-866-306-4256 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Manufactured for: Leading Pharma, LLC 3 Oak Road, Fairfield, NJ 07004-2402 USA www.leadingpharma.com Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310 Iss. 09/18
Indications & Usage
INDICATIONS AND USAGE Ciclopirox Topical Suspension, 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; ; cutaneous candidiasis (moniliasis) due to Candida albicans; and tinea (pityriasis) versicolor due to Malassezia furfur.
Dosage and Administration
DOSAGE AND ADMINISTRATION Gently massage Ciclopirox Topical Suspension, USP 0.77% into the affected and surrounding skin areas twice daily, in the morning and evening. Clinical improvement with relief of pruritus 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 Topical Suspension, USP 0.77%, the diagnosis should be redetermined. Patients with tinea versicolor usually exhibit clinical and mycological clearing after two weeks of treatment.