Lidocan
Lidocan Patch Lidocaine Patch 5% Rx only
Approved
Approval ID
fd8e4856-3785-4850-e053-6294a90a95b6
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 14, 2023
Manufacturers
FDA
PURETEK CORPORATION
DUNS: 785961046
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine 5%
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code59088-905
Application NumberANDA209190
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine 5%
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 14, 2023
FDA Product Classification
INGREDIENTS (17)
WATERInactive
Code: 059QF0KO0R
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
POLYACRYLIC ACID (8000 MW)Inactive
Code: 73861X4K5F
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
UREAInactive
Code: 8W8T17847W
Classification: IACT
SODIUM POLYACRYLATE (8000 MW)Inactive
Code: 285CYO341L
Classification: IACT
KAOLINInactive
Code: 24H4NWX5CO
Classification: IACT
TARTARIC ACIDInactive
Code: W4888I119H
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
EDETATE DISODIUMInactive
Code: 7FLD91C86K
Classification: IACT
DIHYDROXYALUMINUM AMINOACETATEInactive
Code: DO250MG0W6
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORMInactive
Code: K679OBS311
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
LIDOCAINEActive
Quantity: 700 mg in 1 1
Code: 98PI200987
Classification: ACTIB