LIDOCAINE (Page 4 of 4)


– 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.


  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 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)

Made in Canada for:

NDC, Inc., 402 BNA Drive, Suite 500

Nashville, TN 37217 |

PRINCIPAL DISPLAY PANEL -- 1.7 mL Cartridge Carton
(click image for full-size original)
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
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
# 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)
Name Address ID/FEI Operations
Novocol Pharmaceutical of Canada, Inc. 201719960 MANUFACTURE (43128-105)

Revised: 08/2022 NDC, Inc.

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