1 INDICATIONS AND USAGE Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is indicated for ophthalmic procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic agent.

Altafluor Benox (fluorescein sodium and benoxinate hydrochloride ophthalmic solution) 0.25%/0.4% is a combination disclosing agent and local ester anesthetic indicated for procedures requiring a disclosing agent in combination with a topical ophthalmic anesthetic.

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6 ADVERSE REACTIONS The following 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 0.25% / 0.4%: ocular hyperemia, burning, stinging, eye irritation, blurred vision and punctate keratitis.

Because these reactions were 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 Altaire Pharmaceuticals, Inc., at 1-800-258-2471 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.