CICLOPIROX OLAMINE
Ciclopirox Topical Suspension, USP 0.77% For Topical Use OnlyNot for use in eyes Rx Only
Approved
Approval ID
370ab878-2753-435f-ae06-67ec9f9502e1
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2020
Manufacturers
FDA
Leading Pharma, LLC
DUNS: 079575060
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CICLOPIROX OLAMINE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code69315-309
Application NumberNDA019824
Product Classification
M
Marketing Category
C73605
G
Generic Name
CICLOPIROX OLAMINE
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 30, 2020
FDA Product Classification
INGREDIENTS (10)
CICLOPIROX OLAMINEActive
Quantity: 7.7 mg in 1 mL
Code: 50MD4SB4AP
Classification: ACTIM
MINERAL OILInactive
Code: T5L8T28FGP
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
COCAMIDEInactive
Code: 3YXD33R71G
Classification: IACT
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
MYRISTYL ALCOHOLInactive
Code: V42034O9PU
Classification: IACT
LACTIC ACIDInactive
Code: 33X04XA5AT
Classification: IACT
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT