Lidocaine and Prilocaine
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP
Approved
Approval ID
1972d657-2d5a-4697-bba9-80caffc2f2d7
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jul 31, 2019
Manufacturers
FDA
Actavis Pharma, Inc.
DUNS: 119723554
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
lidocaine and prilocaine
PRODUCT DETAILS
NDC Product Code0591-2070
Application NumberNDA019941
Marketing CategoryC73605
Route of AdministrationTOPICAL
Effective DateJuly 31, 2019
Generic Namelidocaine and prilocaine
INGREDIENTS (6)
LIDOCAINEActive
Quantity: 25 mg in 1 g
Code: 98PI200987
Classification: ACTIB
PRILOCAINEActive
Quantity: 25 mg in 1 g
Code: 046O35D44R
Classification: ACTIB
CARBOMER 934Inactive
Code: Z135WT9208
Classification: IACT
PEG-55 HYDROGENATED CASTOR OILInactive
Code: 0WZF1506N9
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT