LULICONAZOLE
These highlights do not include all the information needed to use Luliconazole Cream safely and effectively. See full prescribing information for Luliconazole Cream. Luliconazole cream, for topical useInitial U.S. Approval: 2013
Approved
Approval ID
7ccda3ba-9c98-468d-83c6-7f0cc7c88c33
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 30, 2020
Manufacturers
FDA
Oceanside Pharmaceuticals
DUNS: 832011691
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
LULICONAZOLE
PRODUCT DETAILS
NDC Product Code68682-850
Application NumberNDA204153
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateApril 30, 2020
Generic NameLULICONAZOLE
INGREDIENTS (11)
CETOSTEARYL ALCOHOLInactive
Code: 2DMT128M1S
Classification: IACT
BUTYLATED HYDROXYTOLUENEInactive
Code: 1P9D0Z171K
Classification: IACT
POLYSORBATE 60Inactive
Code: CAL22UVI4M
Classification: IACT
ISOPROPYL MYRISTATEInactive
Code: 0RE8K4LNJS
Classification: IACT
MEDIUM-CHAIN TRIGLYCERIDESInactive
Code: C9H2L21V7U
Classification: IACT
SORBITAN MONOSTEARATEInactive
Code: NVZ4I0H58X
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
LULICONAZOLEActive
Quantity: 10 mg in 1 g
Code: RE91AN4S8G
Classification: ACTIB
BENZYL ALCOHOLInactive
Code: LKG8494WBH
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT