Drug Catalog - Product Detail
CICLOPIROX OLAMINE GEL GEL 0.0077 45GM
| NDC | Mfr | Size | Str | Form |
|---|---|---|---|---|
| 68462-0455-47 | GLENMARK PHARMACEUTICALS | 45 | 0.77% | GEL |
PACKAGE FILES
Generic Name
CICLOPIROX
Substance Name
CICLOPIROX
Product Type
HUMAN PRESCRIPTION DRUG
Route
TOPICAL
Application Number
ANDA091595
Description
DESCRIPTION Ciclopirox gel 0.77% contains a synthetic antifungal agent, ciclopirox USP. It is intended for topical dermatologic use only. Each gram of ciclopirox gel contains 7.70 mg of ciclopirox USP in a gel consisting of carbomer homopolymer, isopropyl alcohol, and medium chain triglycerides, sodium hydroxide, sodium lauryl sulfate, and purified water. Ciclopirox gel is a white, slightly fluid gel. The chemical name for ciclopirox USP 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: structure
How Supplied
HOW SUPPLIED Ciclopirox gel 0.77% is supplied in aluminium tubes and LDPE tubes. 30 g tubes (NDC 68462-455-35), 45 g tubes (NDC 68462-455-47) and 100 g tubes (NDC 68462-455-94). Store at 20 to 25°C (68 to 77°F) [See USP Controlled Room Temperature]. Manufactured by: Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403 513, India Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888)721-7115 www.glenmarkpharma.com/usa January 2017
Indications & Usage
INDICATIONS AND USAGE Superficial Dermatophyte Infections Ciclopirox gel 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 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 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 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.