GENERAL SURGERY TRAY- kit

General Surgery Tray by

Drug Labeling and Warnings

General Surgery Tray by is a Other medication manufactured, distributed, or labeled by Centurion Medical Products, E. Fougera & Co.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Description

NOT FOR OPHTHALMIC USE
FOR EXTERNAL USE ONLY
Rx only

General Surgery Tray Primary Label

Lidocaine and Prilocaine Label

INGREDIENTS AND APPEARANCE

GENERAL SURGERY TRAY 
tray, surgical kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1521

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:24840-1521-1	1 in 1 PACKAGE, COMBINATION
2	NHRIC:24840-1521-2	1 in 1 CASE

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	5 g

Part 1 of 1

LIDOCAINE AND PRILOCAINE 
lidocaine and prilocaine cream

Product Information
Item Code (Source)	NDC: 0168-0357
Route of Administration	Topical

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE	25 mg  in 1 g
PRILOCAINE (UNII: 046O35D44R) (PRILOCAINE - UNII:046O35D44R)	PRILOCAINE	25 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER TYPE B (ALLYL SUCROSE CROSSLINKED) (UNII: Z135WT9208)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0168-0357-55	5 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA076453	08/18/2003

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
exempt device	LRP	01/01/2013

Labeler - Centurion Medical Products (017246562)

Establishment
Name	Address	ID/FEI	Business Operations
Centurion Medical Products		017246562	manufacture, repack

Establishment
Name	Address	ID/FEI	Business Operations
Centurion Medical Products		148522279	manufacture, repack

Establishment
Name	Address	ID/FEI	Business Operations
Centurion Medical Products		626660810	manufacture, repack

Establishment
Name	Address	ID/FEI	Business Operations
E. Fougera & Co.		043838424	manufacture