Lidocaine and Tetracaine
These highlights do not include all the information needed to use LIDOCAINE AND TETRACAINE CREAM safely and effectively. See full prescribing information for LIDOCAINE AND TETRACAINE CREAM. LIDOCAINE AND TETRACAINE cream, for topical use Initial U.S. Approval: 2006
Approved
Approval ID
db56db69-969e-4d35-93ce-f1208a965631
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 20, 2021
Manufacturers
FDA
Innovida Pharmaceutique Corporation
DUNS: 080892908
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Lidocaine and Tetracaine
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code71800-631
Application NumberNDA021717
Product Classification
M
Marketing Category
C73605
G
Generic Name
Lidocaine and Tetracaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 20, 2021
FDA Product Classification
INGREDIENTS (9)
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
LIDOCAINEActive
Quantity: 70 mg in 1 g
Code: 98PI200987
Classification: ACTIB
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITAN MONOPALMITATEInactive
Code: 77K6Z421KU
Classification: IACT
TETRACAINEActive
Quantity: 70 mg in 1 g
Code: 0619F35CGV
Classification: ACTIB