Dressing Change Tray: Package Insert and Label Information

DRESSING CHANGE TRAY-
Centurion Medical Products

DESCRIPTION

Lidocaine Hydrochloride Injection, USP is a sterile, nonpyrogenic solution of lidocaine hydrochloride in water for injection for parenteral administration in various concentrations. Multiple-dose vials contain 0.1% of methylparaben added as preservative. May contain sodium hydroxide and/or cydrochloric adic for pH adjustment. The pH is 6.5 (5.0 to 7.0). Lidocaine is a local anesthetic of the amide type. Lidocaine Hydrochloride is a white powder freely soluable in water. The molecular weight is 288.82. The semi-rigid vial used for the plastic vials is fabricated from a specially formulated polyolefin. It is a copolymer of ethylene and propylene. The safety of the plastic has been confirmed by tests in animals according to USP biological standards for plastic containers. The container requires no vapor barrier to maintain the proper drug concentration.

Dressing Change Tray Primary Label

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Lidocaine Label

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Established Pharmacological Class
Substance Pharmacological Class
Dressing Change Tray Dressing Change Tray
DRESSING CHANGE TRAY
kit
Product Information
Product Type Item Code (Source) NHRIC:24840-1902
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:24840-1902-2 10 PACKAGE, COMBINATION in 1 CASE contains a PACKAGE, COMBINATION (24840-1902-1)
1 NHRIC:24840-1902-1 1 KIT in 1 PACKAGE, COMBINATION This package is contained within the CASE (24840-1902-2)
Quantity of Parts
Part # Package Quantity Total Product Quantity
Part 1 1 AMPULE 2 mL
Part 1 of 1
LIDOCAINE HYDROCHLORIDE
lidocaine hydrochloride anhydrous injection, solution
Product Information
Item Code (Source) NDC:0409-4713
Route of Administration INFILTRATION DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LIDOCAINE HYDROCHLORIDE ANHYDROUS (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
SODIUM CHLORIDE 7 mg in 1 mL
WATER
SODIUM HYDROXIDE
HYDROCHLORIC ACID
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0409-4713-32 2 mL in 1 AMPULE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA080408 03/30/2010
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
exempt device OKV 01/01/2012
Labeler — Centurion Medical Products (017246562)
Establishment
Name Address ID/FEI Operations
Centurion Medical Products 017246562 manufacture, repack
Establishment
Name Address ID/FEI Operations
Centurion Medical Products 148522279 manufacture, repack
Establishment
Name Address ID/FEI Operations
Centurion Medical Products 626660810 manufacture, repack
Establishment
Name Address ID/FEI Operations
Hospira 093132819 manufacture

Revised: 05/2012 Centurion Medical Products

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