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warnings and cautions
5 WARNINGS AND PRECAUTIONS Corneal Toxicity : Prolonged use or abuse may lead to corneal epithelial toxicity and manifest as epithelial defects which may progress to permanent corneal damage. ( Error! Hyperlink reference not valid. ) Corneal Injury : Patients should not touch the eye for approximately 20 minutes after using anesthetic as accidental injuries can occur due to insensitivity of the eye. ( 5.2 ) 5.1 Corneal Toxicity Prolonged use or abuse may lead to corneal epithelial toxicity and may manifest as epithelial defects which may progress to permanent corneal damage with accompanying visual loss. 5.2 Corneal Injury Due to Insensitivity Patients should not touch the eye for approximately 20 minutes after using this anesthetic as accidental injuries can occur due to insensitivity of the eye.
6 ADVERSE REACTIONS The following serious ocular adverse reactions are described elsewhere in the labeling: Corneal Toxicity [see Warnings and Precautions (5.1) ] Corneal Injury Due to Insensitivity [see Warnings and Precautions (5.2) ] The following adverse reactions have been identified following use of Fluorescein Sodium and Benoxinate Hydrochloride Ophthalmic Solution, 0.3%/0.4%: ocular hyperemia, burning, stinging, eye irritation, blurred vision and punctate keratitis. 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. The most common ocular adverse events are stinging, burning and conjunctival redness. ( 6) To report SUSPECTED ADVERSE REACTIONS, contact Bausch & Lomb Incorporated at 1-800-553-5340 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.