LIDOPRIL
LIDOPRIL ( Lidocaine 2.5% and Prilocaine 2.5% Cream, USP)
Approved
Approval ID
1edfa2e0-8a9a-4c15-8688-61193d75178a
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Aug 17, 2016
Manufacturers
FDA
Sterling-knight Pharmaceuticals,LLC
DUNS: 079556942
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine 2.5% and Prilocaine 2.5%
PRODUCT DETAILS
NDC Product Code69336-825
Application NumberNDA019941
Marketing CategoryC73594
Route of AdministrationTOPICAL
Effective DateAugust 16, 2016
Generic NameLidocaine 2.5% and Prilocaine 2.5%
INGREDIENTS (7)
LIDOCAINEActive
Quantity: 25 mg in 1 g
Code: 98PI200987
Classification: ACTIB
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED)Inactive
Code: Z135WT9208
Classification: IACT
PRILOCAINEActive
Quantity: 25 mg in 1 g
Code: 046O35D44R
Classification: ACTIB
PEG-55 HYDROGENATED CASTOR OILInactive
Code: 0WZF1506N9
Classification: IACT
CARBOXYPOLYMETHYLENEInactive
Code: 0A5MM307FC
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32I
Classification: IACT