Septocaine and Epinephrine (Page 5 of 5)

17 PATIENT COUNSELING INFORMATION

Loss of Sensation and Muscle Function:

Inform patients in advance of the possibility of temporary loss of sensation and muscle function following infiltration and nerve block injections [see Adverse Reactions (6.2)]. Instruct patients not to eat or drink until normal sensation returns.

Methemoglobinemia:

Inform patients that use of local anesthetics may cause methemoglobinemia, a serious condition that must be treated promptly. Advise patients or caregivers to seek immediate medical attention if they or someone in their care experience the following signs or symptoms: pale, gray, or blue colored skin (cyanosis); headache; rapid heart rate; shortness of breath; lightheadedness; or fatigue.

Manufactured for SEPTODONT Inc
205 Granite Run Dr., Suite 150, Lancaster, PA, USA 17601
by Novocol Pharmaceutical of Canada Inc.
Cambridge, Ontario, Canada N1R 6X3

Rev 10/2019 (2552-6)

PRINCIPAL DISPLAY PANEL — 1.7 mL Cartridge Carton

FOR INFILTRATION AND NERVE BLOCK ANESTHESIA. NDC 0362-9049-02

Septocaine® (articaine HCl and epinephrine) Injection

Articaine Hydrochloride 4% (40 mg/mL) and Epinephrine 1:100,000

(Articaine Hydrochloride and Epinephrine Injection, USP)

Intraoral Submucosal Injection

Contains sodium metabisulfite.See warnings section of insert for details.

50 single-dose cartridges: 1.7 mL each

Manufactured for SEPTODONT, INC.

205 Granite Run Dr., Suite 150, Lancaster, PA, USA 17601

by Novocol Pharmaceutical of Canada, Inc.

Cambridge, ON N1R 6X3, Canada

PRINCIPAL DISPLAY PANEL — 1.7 mL Cartridge Carton

FOR INFILTRATION AND NERVE BLOCK ANESTHESIA. NDC 0362-9048-02

Septocaine® (articaine HCl and epinephrine) Injection
Articaine Hydrochloride 4% (40 mg/mL) and Epinephrine 1:200,000
(Articaine Hydrochloride and Epinephrine Injection, USP)

Intraoral Submucosal Injection

Contains sodium metabisulfite.
See warnings section of insert for details.

50 single-dose cartridges: 1.7 mL each

Manufactured for SEPTODONT, INC.
205 Granite Run Dr., Suite 150, Lancaster, PA, USA 17601
by Novocol Pharmaceutical of Canada, Inc. Cambridge, ON N1R 6X3, Canada

PRINCIPAL DISPLAY PANEL — 1.7 mL Cartridge Carton

FOR INFILTRATION AND NERVE BLOCK ANESTHESIA. NDC 0362-9049-02

Septocaine® (articaine HCl and epinephrine) Injection
Articaine hydrochloride 4% (40 mg/mL) and epinephrine 1:100,000

(Articaine Hydrochloride and Epinephrine Injection, USP)

Intraoral Submucosal Injection
Contains sodium metabisulfite.
See warnings section of insert for details.

50 single-dose cartridges: 1.7 mL each

Made by SEPTODONT
94100 Saint-Maur-des-FossesFrance

SEPTOCAINE AND EPINEPHRINE articaine hydrochloride and epinephrine bitartrate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0362-9049 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Articaine Hydrochloride (Articaine) Articaine Hydrochloride 40 mg in 1 mL Epinephrine Bitartrate (Epinephrine) Epinephrine 0.01 mg in 1 mL

Inactive Ingredients Ingredient Name Strength Sodium chloride 1.6 mg in 1 mL Sodium metabisulfite 0.5 mg in 1 mL Water Sodium hydroxide

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0362-9049-02 50 CARTRIDGE in 1 CARTON contains a CARTRIDGE 1 1.7 mL in 1 CARTRIDGE This package is contained within the CARTON (0362-9049-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020971 01/12/2011

SEPTOCAINE AND EPINEPHRINE articaine hydrochloride and epinephrine bitartrate injection, solution

Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0362-9048 Route of Administration SUBCUTANEOUS DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Articaine Hydrochloride (Articaine) Articaine Hydrochloride 40 mg in 1 mL Epinephrine Bitartrate (Epinephrine) Epinephrine 0.005 mg in 1 mL

Inactive Ingredients Ingredient Name Strength Sodium chloride 1.6 mg in 1 mL Sodium metabisulfite 0.5 mg in 1 mL Water Sodium hydroxide

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:0362-9048-02 50 CARTRIDGE in 1 CARTON contains a CARTRIDGE 1 1.7 mL in 1 CARTRIDGE This package is contained within the CARTON (0362-9048-02)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA020971 01/12/2011

Labeler — Septodont Inc. (627058738)

Registrant — Septodont Inc. (627058738)

Establishment
Name	Address	ID/FEI	Operations
Novocol Pharmaceutical of Canada, Inc.		201719960	manufacture (0362-9049), manufacture (0362-9048)

Establishment
Name	Address	ID/FEI	Operations
Septodont SAS Specialites Septodont		275273795	manufacture (0362-9049)

Revised: 11/2021 Septodont Inc.