Oxiconazole Nitrate
OXICONAZOLE NITRATE CREAM, 1%* *Potency expressed as oxiconazole Rx only FOR TOPICAL DERMATOLOGIC USE ONLY – NOT FOR OPHTHALMIC OR INTRAVAGINAL USE.
Approved
Approval ID
aa368d2b-a5d2-49dd-86e1-5693b68b46f4
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Sep 14, 2020
Manufacturers
FDA
E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
DUNS: 043838424
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Oxiconazole Nitrate
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0168-0358
Application NumberNDA019828
Product Classification
M
Marketing Category
C73605
G
Generic Name
Oxiconazole Nitrate
Product Specifications
Route of AdministrationTOPICAL
Effective DateFebruary 13, 2019
FDA Product Classification
INGREDIENTS (8)
CETYL ALCOHOLInactive
Code: 936JST6JCN
Classification: IACT
OXICONAZOLE NITRATEActive
Quantity: 10 mg in 1 g
Code: RQ8UL4C17S
Classification: ACTIM
WATERInactive
Code: 059QF0KO0R
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
STEARYL ALCOHOLInactive
Code: 2KR89I4H1Y
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
BENZOIC ACIDInactive
Code: 8SKN0B0MIM
Classification: IACT