Octocaine 50 (Page 4 of 4)

PRINCIPAL DISPLAY PANEL — 1.7 mL Cartridge Carton

NDC 0362-9010-05

Octocaine 50

LIDOCAINE HCl 2% and EPINEPHRINE 1:50,000 Injection

(LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION,USP)

50 Cartridges • 1.7 mL each

FOR DENTAL BLOCK AND INFILTRATION ONLY

Rx Only

PRINCIPAL DISPLAY PANEL -- 1.7 mL Cartridge Carton
(click image for full-size original)
OCTOCAINE 50
lidocaine hydrochloride and epinephrine bitartrate injection, solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0362-9010
Route of Administration SUBCUTANEOUS DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Lidocaine Hydrochloride (Lidocaine) Lidocaine Hydrochloride 20 mg in 1 mL
Epinephrine Bitartrate (Epinephrine) Epinephrine 0.02 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:0362-9010-05 50 CARTRIDGE (CARTRIDGE) in 1 CARTON contains a CARTRIDGE
1 1.7 mL in 1 CARTRIDGE This package is contained within the CARTON (0362-9010-05)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA088389 11/07/2011
Labeler — Septodont (627058738)
Registrant — Novocol Pharmaceutical of Canada, Inc. (201719960)
Establishment
Name Address ID/FEI Operations
Novocol Pharmaceutical of Canada, Inc. 201719960 MANUFACTURE

Revised: 12/2011 Septodont

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