FDA label bb57078b-c74f-41e3-bcaf-51225b4fb526

openFDA label record#

This page contains supplementary openFDA label data. For the canonical label presentation, use the corresponding DailyMed Structured Product Label.

Verified complete openFDA source JSON (canonical bytes are SHA-256 checked before publication)

SPL set ID
dae037ad-dcb8-42e6-8996-e575922d7631
SPL ID
bb57078b-c74f-41e3-bcaf-51225b4fb526
Version
10
Effective date
2022-10-28
Source export date
2026-10-12
Source partition
14
Source file
https://download.open.fda.gov/drug/label/drug-label-0014-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/acb9b4700b9af1bdda1c389c7b35bfe38fd6d1a62aa48d17832812be4029b84f/drug-label-0014-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:13:59

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: Avoid contamination - do not touch tip of sterile dropper used to dispense solution to any surface. Replace container closure immediately after using. Prolonged use of a topical ocular anesthetic is not recommended. It may product permanent corneal opacification with accompanying visual loss.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS: Occasional temporary stinging, burning, and conjunctival redness have been reported after use of ocular anesthetics, as well as a rare, severe, immediate-type, apparent hyper-allergic corneal reaction, with acute, intense and diffuse epithelial keratitis, a gray, ground glass appearance, sloughing of large areas of necrotic epithelium, corneal filaments and sometimes, iritis with descementitis. Allergic contact dermatitis with drying and fissuring of the fingertips has been reported. To report SUSPECTED ADVERSE REACTIONS, contact Altaire Pharmaceuticals, Inc. at (631) 722-5988.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.