LIDOCAINE AND PRILOCAINE
LIDOCAINE and PRILOCAINE CREAM, 2.5%/2.5%
Approved
Approval ID
2a9976e3-4595-4bc5-b7f9-f4a9bd59e55d
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 1, 2010
Manufacturers
FDA
Physicians Total Care, Inc.
DUNS: 194123980
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 Code54868-5194
Application NumberANDA076453
Product Classification
M
Marketing Category
C73584
G
Generic Name
Lidocaine and Prilocaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateMarch 24, 2011
FDA Product Classification
INGREDIENTS (4)
lidocaineActive
Quantity: 25 mg in 1 g
Code: 98PI200987
Classification: ACTIB
prilocaineActive
Quantity: 25 mg in 1 g
Code: 046O35D44R
Classification: ACTIB
sodium hydroxideInactive
Code: 55X04QC32I
Classification: IACT
waterInactive
Code: 059QF0KO0R
Classification: IACT