Ciclopirox
Ciclopirox Topical Solution, 8%
Approved
Approval ID
02f46b6e-b424-4210-83bf-e79618df4344
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 24, 2023
Manufacturers
FDA
Padagis Israel Pharmaceuticals Ltd
DUNS: 600093611
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Ciclopirox
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code45802-141
Application NumberANDA077623
Product Classification
M
Marketing Category
C73584
G
Generic Name
Ciclopirox
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 7, 2017
FDA Product Classification
INGREDIENTS (3)
CICLOPIROXActive
Quantity: 80 mg in 1 mL
Code: 19W019ZDRJ
Classification: ACTIB
ETHYL ACETATEInactive
Code: 76845O8NMZ
Classification: IACT
ISOPROPYL ALCOHOLInactive
Code: ND2M416302
Classification: IACT
Drug Labeling Information
HOW SUPPLIED SECTION
LOINC: 34069-5Updated: 11/17/2008
HOW SUPPLIED
Ciclopirox Topical Solution, 8% is available as follows:
6.6 mL glass bottle with a screw cap fitted with a brush (NDC 45802-141-67)
Protect from light (store bottle in the carton after every use).
Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].
CAUTION: Flammable. Keep away from heat and flame.