SPL Set ID: 864e511b-cc50-4ed9-b122-8e1a93457332

Sterile isotonic solutions containing a local anesthetic agent, Lidocaine Hydrochloride, and a vasoconstrictor, epinephrine (as bitartrate) and are administered parenterally by injection. Both solutions are available in single dose cartridges of 1.7 mL (See INDICATIONS AND USAGE for specific uses). Solutions contain lidocaine hydrochloride which is chemically designated as acetamide, 2-(diethylamino)-N-(2,6-dimethylphenyl)-monohydrochloride, and has the following structural formula: C 14 H 22 N 2 0 • HCl • H 2 0 M.W. 288.8 Epinephrine is ( - )-3, 4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula: C 9 H 13 N0 3 M.W. 183.21 COMPOSITION OF LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE INJECTION, USP BRAND NAME PRODUCT IDENTIFICATION FORMULA SINGLE DOSE CARTRIDGE Lidocaine hydrochloride Epinephrine (as the bitartrate) Sodium Chloride Potassium metabisulfite Edetate Disodium Concentration % Dilution (mg/mL) (mg/mL) (mg/mL) LIDOCAINE HCl 2% and EPINEPHRINE 1:50,000 2 1:50,000 6.5 1.2 0.25 LIDOCAINE HCl 2% and EPINEPHRINE 1:100,000 2 1:100,000 6.5 1.2 0.25 The pH of the lidocaine hydrochloride and epinephrine injection, USP solutions are adjusted to USP limits with sodium hydroxide. lidocaine hydrochloride Epinephrine