LICART
These highlights do not include all the information needed to use LICART safely and effectively. See full prescribing information for LICART. LICART (diclofenac epolamine) topical system Initial U.S. Approval: 1988
Approved
Approval ID
851c8b39-6056-4bbc-812e-b9b13977c1ac
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Dec 1, 2023
Manufacturers
FDA
IBSA Pharma Inc.
DUNS: 081215551
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
diclofenac epolamine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71858-0305
Application NumberNDA206976
Product Classification
M
Marketing Category
C73594
G
Generic Name
diclofenac epolamine
Product Specifications
Route of AdministrationTOPICAL
Effective DateDecember 1, 2023
FDA Product Classification
INGREDIENTS (17)
BUTYLENE GLYCOLInactive
Code: 3XUS85K0RA
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
HEPARIN SODIUMInactive
Code: ZZ45AB24CA
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
POLYSORBATE 80Inactive
Code: 6OZP39ZG8H
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDInactive
Code: K679OBS311
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
DICLOFENAC EPOLAMINEActive
Quantity: 0.013 g in 1 1
Code: X5F8EKL9ZG
Classification: ACTIB