RVP

Drug Catalog - Product Detail

CICLOPIROX OLAMINE GEL GEL 0.0077 30GM

NDC Mfr Size Str Form
00574-2061-30 PADAGIS 30 0.77% GEL
Product Image

PACKAGE FILES

Package Image
Package Image
Package Image
Generic Name
CICLOPIROX
Substance Name
CICLOPIROX
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA078266
Description
DESCRIPTION Ciclopirox Gel, 0.77% contains a synthetic antifungal agent, ciclopirox. It is intended for topical dermatologic use only. Each gram of Ciclopirox Gel, 0.77% contains 7.70 mg of ciclopirox in a gel consisting of Purified Water USP, Isopropyl Alcohol USP, Octyldodecanol NF, Dimethicone Copolyol 190, Carbomer 980, Sodium Hydroxide NF, and Docusate Sodium USP. Ciclopirox Gel, 0.77% is a white, slightly fluid gel. The chemical name for ciclopirox is 6-cyclohexyl-1-hydroxy-4-methyl-2(1 H )- pyridinone, with the empirical formula C 12 H 17 NO 2 and a molecular weight of 207.27. The CAS Registry Number is [29342-05-0]. The chemical structure is: Ciclopirox Gel Structural Formula
How Supplied
HOW SUPPLIED Ciclopirox Gel, 0.77% is supplied in 30 g tubes (NDC 0574- 2061 -30), 45 g tubes (NDC 0574- 2061 -45) and 100 g tubes (NDC 0574- 2061 -01). Store at 20°–25°C (68°–77°F) [see USP Controlled Room Temperature]. Manufactured By Perrigo® Minneapolis, MN 55427 2201422 : 8D700 RC J1 Rev 10-13 B
Indications & Usage
INDICATIONS AND USAGE Superficial Dermatophyte Infections Ciclopirox Gel, 0.77% is indicated for the topical treatment of interdigital tinea pedis and tinea corporis due to Trichophyton rubrum, Trichophyton mentagrophytes, or Epidermophyton floccosum . Seborrheic Dermatitis Ciclopirox Gel, 0.77% is indicated for the topical treatment of seborrheic dermatitis of the scalp.
Dosage and Administration
DOSAGE AND ADMINISTRATION Superficial Dermatophyte Infections Gently massage Ciclopirox Gel, 0.77% into the affected areas and surrounding skin twice daily, in the morning and evening immediately after cleaning or washing the areas to be treated. Interdigital tinea pedis and tinea corporis should be treated for 4 weeks. If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed. Seborrheic Dermatitis of the Scalp Apply Ciclopirox Gel, 0.77% to affected scalp areas twice daily, in the morning and evening for 4 weeks. Clinical improvement usually occurs within the first week with continuing resolution of signs and symptoms through the fourth week of treatment. If a patient shows no clinical improvement after 4 weeks of treatment, the diagnosis should be reviewed.