Pliaglis
These highlights do not include all the information needed to use PLIAGLIS safely and effectively. See full prescribing information for PLIAGLIS. This package includes 1 unit of Pliaglis and 10 Alcohol Prep Pads PLIAGLIS (lidocaine and tetracaine) cream, for topical use Initial U.S. Approval: 2006
Approved
Approval ID
4ccdf61b-3128-4a97-a89c-a11e40823938
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Oct 6, 2020
Manufacturers
FDA
Oba Pharmaceuticals, Inc.
DUNS: 117380833
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 Code73575-010
Application NumberNDA021717
Product Classification
M
Marketing Category
C73594
G
Generic Name
lidocaine and tetracaine
Product Specifications
Route of AdministrationTOPICAL
Effective DateOctober 6, 2020
FDA Product Classification
INGREDIENTS (9)
lidocaineActive
Quantity: 70 mg in 1 g
Code: 98PI200987
Classification: ACTIB
tetracaineActive
Quantity: 70 mg in 1 g
Code: 0619F35CGV
Classification: ACTIB
METHYLPARABENInactive
Code: A2I8C7HI9T
Classification: IACT
PETROLATUMInactive
Code: 4T6H12BN9U
Classification: IACT
PROPYLPARABENInactive
Code: Z8IX2SC1OH
Classification: IACT
ANHYDROUS DIBASIC CALCIUM PHOSPHATEInactive
Code: L11K75P92J
Classification: IACT
POLYVINYL ALCOHOL, UNSPECIFIEDInactive
Code: 532B59J990
Classification: IACT
SORBITAN MONOPALMITATEInactive
Code: 77K6Z421KU
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT