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
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code0591-2070
Application NumberNDA019941
Product Classification
M
Marketing Category
C73605
G
Generic Name
lidocaine and prilocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateJuly 31, 2019
FDA Product Classification
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