SPL Set ID: 6f9477b5-699f-4d3b-b9a6-0cc238266237

LOTEMAX ® SM (loteprednol etabonate ophthalmic gel) 0.38% contains a sterile, topical corticosteroid for ophthalmic use. Loteprednol etabonate is a white to off-white powder. Loteprednol etabonate is represented by the following structural formula: Chemical Name: chloromethyl 17α-[(ethoxycarbonyl)oxy]-11β-hydroxy-3-oxoandrosta-1,4-diene-17β-carboxylate Each gram contains: • Active: loteprednol etabonate 3.8 mg (0.38%); • Inactives: boric acid, edetate disodium dihydrate, glycerin, hypromellose, poloxamer, polycarbophil, propylene glycol, sodium chloride, water for injection, and sodium hydroxide to adjust to a pH of between 6 and 7. • Preservative: benzalkonium chloride 0.003% chemstructure