LIDOCAINE (Page 4 of 4)

HOW SUPPLIED

– Lidocaine Hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:50,000 injection is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose cartridges.
– Lidocaine Hydrochloride 2% (34 mg/1.7 mL) (20 mg/mL) and Epinephrine 1:100,000 injection is available in cardboard boxes containing 5 blisters of 10 x 1.7 mL single-dose cartridges.

Store at controlled room temperature, below 25°C (77°F). Protect from light. Do not permit to freeze.

BOXES: For protection from light, retain in box until time of use. Once opened, the box should be reclosed by closing the end flap.

Do not use if color is pinkish or darker than slightly yellow or if it contains a precipitate.

STERILIZATION : STORAGE AND TECHNICAL PROCEDURES

1. Cartridges should not be autoclaved, because the closures employed cannot withstand autoclaving temperatures and pressures.
2. If chemical disinfection of anesthetic cartridges is desired, either isopropyl alcohol (91%) or 70% ethyl alcohol is recommended. Many commercially available brands of rubbing alcohol, as well as solutions of ethyl alcohol not of U.S.P grade, contain denaturants that are injurious to rubber and, therefore, are not to be used. It is recommended that chemical disinfection be accomplished just prior to use by wiping the cartridge cap thoroughly with a pledge of cotton that has been moistened with recommended alcohol.
3. Certain metallic ions (mercury, zinc, copper, etc.) have been related to swelling and edema after local anesthesia in dentistry. Therefore, chemical disinfectants containing or releasing these ions are not recommended. Antirust tablets usually contain sodium nitrite or some similar agents that may be capable of releasing metal ions. Because of this, aluminium sealed cartridges should not be kept in such solutions.
4. Quaternary ammonium salts, such as benzalkonium chloride, are electrolytically incompatible with aluminium. Cartridges of Lidocaine and Epinephrine Injections are sealed with aluminium caps and therefore should not be immersed in any solution containing these salts.
5. To avoid leakage of solutions during injection, be sure to penetrate the center of the rubber diaphragm when loading the syringe. An off-center penetration produces an oval shaped puncture that allows leakage around the needle.
   Other causes of leakage and breakage include badly worn syringes, aspirating syringes with bent harpoons, the use of syringes not designed to take 1.7 mL cartridges, and inadvertent freezing.
6. Cracking of glass cartridges is most often the result of an attempt to use a cartridge with an extruded plunger. An extruded plunger loses its lubrication and can be forced back into the cartridge only with difficulty. Cartridges with extruded plungers should be discarded.
7. Store at controlled room temperature, below 25°C (77°F).

Manufactured by: Novocol Pharmaceutical of Canada, Inc.
25 Wolseley Court, Cambridge ON N1R 6X3
Made in Canada

Rev. 07/2021 (2103-4)

PRINCIPAL DISPLAY PANEL — 1.7 mL Cartridge Carton

NDC 43128-105-15

Lidocaine

Lidocaine HCl 2% (34 mg/1.7 mL) (20 mg/mL) and
Epinephrine 1:100,000 Injection
(Lidocaine Hydrochloride and Epinephrine Injection, USP)

REF: 08-A0100

Contains: 50 single-dose cartridges /1.7 mL each

For Dental Block and Infiltration Only

Rx Only

Store below 25°C (77°F)
DO NOT PERMIT TO FREEZE

Made in Canada for:

NDC, Inc., 402 BNA Drive, Suite 500

Nashville, TN 37217 | www.quala.com

LIDOCAINE lidocaine hydrochloride and epinephrine bitartrate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43128-105 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LIDOCAINE HYDROCHLORIDE (LIDOCAINE) LIDOCAINE HYDROCHLORIDE ANHYDROUS 20 mg in 1 mL Epinephrine Bitartrate (Epinephrine) Epinephrine 0.01 mg in 1 mL

Inactive Ingredients Ingredient Name Strength Potassium Metabisulfite 1.2 mg in 1 mL Sodium Chloride 6.5 mg in 1 mL Edetate Disodium 0.25 mg in 1 mL Sodium Hydroxide Water

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:43128-105-15 50 CARTRIDGE in 1 CARTON contains a CARTRIDGE 1 1.7 mL in 1 CARTRIDGE This package is contained within the CARTON (43128-105-15)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA088390 04/10/2015

Labeler — NDC, Inc. (009831413)

Registrant — Novocol Pharmaceutical of Canada, Inc. (201719960)

Establishment
Name	Address	ID/FEI	Operations
Novocol Pharmaceutical of Canada, Inc.		201719960	MANUFACTURE (43128-105)

Revised: 08/2022 NDC, Inc.