GENERAL SURGERY KIT- kit

General Surgery Kit by

Drug Labeling and Warnings

General Surgery Kit by is a Other medication manufactured, distributed, or labeled by Centurion Medical Products, Hospira Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Lidocaine Hydrochloride and Epinephrine Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride and epinephrine in water for injection for parenteral administration in various concentrations. Sodium metabisulfate 0.5 mg/ml and citric acid, anhydrous 0.2 mg/ml added as stabilizers. May contain sodium hydroxide and/or hydrochloric acid to adjust pH; pH is 4.5 (3.3 to 5.5). Single dose ampuls and vials containno bacteriostat or antimicrobial agent. Discard unused portion. Lidocaine is a local anesthetic of the amide type.

Lidocaine Label

General Surgery Procedure Label

MM

INGREDIENTS AND APPEARANCE

GENERAL SURGERY KIT 
general surgery tray (kit) kit

Product Information
Product Type	MEDICAL DEVICE	Item Code (Source)	NHRIC:24840-1511

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:24840-1511-2	10 in 1 CASE
1	NHRIC:24840-1511-1	1 in 1 PACKAGE, COMBINATION

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 AMPULE	5 mL

Part 1 of 1

LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE 
lidocaine hydrochloride anhydrous and epinephrine injection, solution

Product Information
Item Code (Source)	NDC: 0409-1209
Route of Administration	EPIDURAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (UNII: EC2CNF7XFP) (LIDOCAINE - UNII:98PI200987)	LIDOCAINE HYDROCHLORIDE ANHYDROUS	15 mg  in 1 mL
EPINEPHRINE (UNII: YKH834O4BH) (EPINEPHRINE - UNII:YKH834O4BH)	EPINEPHRINE	5 ug  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
SODIUM CHLORIDE (UNII: 451W47IQ8X)	6.5 mg  in 1 mL
SODIUM METABISULFITE (UNII: 4VON5FNS3C)	0.5 mg  in 1 mL
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)	0.2 mg  in 1 mL
SODIUM HYDROXIDE (UNII: 55X04QC32I)
HYDROCHLORIC ACID (UNII: QTT17582CB)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0409-1209-01	5 mL in 1 AMPULE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANDA	ANDA088571	04/05/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
exempt device	LRO	01/01/2012

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
Hospira Inc		093132819	manufacture