Lidocaine and Prilocaine
Lidocaine and Prilocaine Cream, USP 2.5%/2.5%
Approved
Approval ID
d3380195-2f0c-4afd-9500-9e265429f67e
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Apr 12, 2022
Manufacturers
FDA
Aleor Dermaceuticals Limited
DUNS: 871411532
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 Code71589-017
Application NumberANDA213923
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine and Prilocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateApril 12, 2022
FDA Product Classification
INGREDIENTS (6)
LIDOCAINEActive
Quantity: 25 mg in 1 g
Code: 98PI200987
Classification: ACTIB
PEG-54 HYDROGENATED CASTOR OILInactive
Code: 0WZF1506N9
Classification: IACT
PRILOCAINEActive
Quantity: 25 mg in 1 g
Code: 046O35D44R
Classification: ACTIB
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT
CARBOMER HOMOPOLYMER TYPE B (ALLYL PENTAERYTHRITOL CROSSLINKED)Inactive
Code: HHT01ZNK31
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT