SPL Set ID: f902d2b4-28fc-41b1-a9f7-0d1a63c598aa

LIGNOSPAN FORTE and LIGNOSPAN STANDARD 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). LIGNOSPAN 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 • 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 NO 3 M.W. 183.21 COMPOSITION OF THE LIGNOSPAN INJECTIONS BRAND NAME PRODUCT IDENTIFICATION FORMULA SINGLE DOSE CARTRIDGE Lidocaine hydrochloride Epinephrine (as the bitartrate) Sodium Chloride Potassium metabisulfite Edetate Disodium USP (as dihydrate) Concentration % Dilution (mg/mL) (mg/mL) (mg/mL) LIGNOSPAN FORTE 2 1:50,000 6.5 1.2 0.25 LlGNOSPAN STANDARD 2 1:100,000 6.5 1.2 0.25 The pH of the LIGNOSPAN FORTE and the LIGNOSPAN STANDARD solutions are adjusted to USP limits with Sodium Hydroxide or Hydrochloric Acid q.s. to adjust pH. Chemical Structure Chemical Structure