SPL Set ID: 14b55cf9-f7cd-4bb4-a7c5-aba61abadef1

2% Xylocaine DENTAL with Epinephrine 1:50,000 and 2% Xylocaine DENTAL with Epinephrine 1:100,000 are 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). 2% Xylocaine DENTAL 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 O • HCI • H 2 O M.W. 288.8 Epinephrine is (-)-3,4-Dihydroxy-α-[(Methylamino) methyl] benzyl alcohol and has the following structural formula: C 9 H 13 NO 3 M.W. 183.21 The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. COMPOSITION OF THE 2% Xylocaine DENTAL INJECTIONS 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) 2% Xylocaine Dental with Epinephrine 1:50,000 2 1:50,000 6.5 1.2 0.25 2% Xylocaine Dental with Epinephrine 1:100,000 2 1:100,000 6.5 1.2 0.25 The pH of the 2% Xylocaine DENTAL solutions are adjusted to USP limits with sodium hydroxide. Lidocaine Hydrochloride Epinephrine