SPL Set ID: db23a56f-1e41-4843-9220-1b2e3059db41

4% Citanest Plain Dental, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), (prilocaine HCl Injection, USP), is a sterile, non pyrogenic isotonic solution that contains a local anesthetic agent and is administered parenterally by injection. See INDICATIONS AND USAGE for specific uses. The quantitative composition is shown in Table 1. 4% Citanest Plain Dental, Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL), contains prilocaine HCl, which is chemically designated as propanamide, N-(2-methyl-phenyl) -2- (propylamino)-, monohydrochloride and has the following structural formula: C 13 H 20 N 2 O ∙ HCl molecular wt = 256.77 Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. The specific quantitative composition is shown in Table 1. TABLE 1. COMPOSITION Product Identification Formula (mg/mL) Prilocaine HCl pH Note: Sodium hydroxide or hydrochloric acid may be used to adjust the pH of 4% Citanest Plain Dental Injection (Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL)). 4% Citanest Plain Dental (Prilocaine Hydrochloride Injection, USP, 4% (72 mg/1.8 mL) (40 mg/mL)) 40.0 6.0 to 7.0 Chemical Structure