1 INDICATIONS AND USAGE Tetracaine hydrochloride ophthalmic solution, 0.5% is indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.

Tetracaine hydrochloride ophthalmic solution, 0.5%, is an ester local anesthetic indicated for procedures requiring a rapid and short-acting topical ophthalmic anesthetic.

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6 ADVERSE REACTIONS The following serious ocular adverse reactions are described elsewhere in the labeling: Corneal Injury with Intracameral Use [ see Warnings and Precautions (5.1)] Corneal Toxicity [ see Warnings and Precautions ( 5.2)] Corneal Injury Due to Insensitivity [ see Warnings and Precautions ( 5.3)] The following adverse reactions have been identified following use of tetracaine hydrochloride ophthalmic solution, 0.5%.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

Ocular Adverse Reactions Transient stinging, burning, and conjunctival redness, eye irritation, eye pain, ocular discomfort.

Ocular adverse events: transient stinging, burning, conjunctival redness, eye irritation, eye pain, ocular discomfort.

(6) To report SUSPECTED ADVERSE REACTIONS, contact Somerset Therapeutics, LLC at +1 800-417-9175 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.