FDA.reportPublic FDA data

FDA label 49b97172-cd18-47af-8412-f858d31db88a

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
eee80ec9-495f-413d-b3d6-03924e9d2a02
SPL ID
49b97172-cd18-47af-8412-f858d31db88a
Version
5
Effective date
2022-05-20
Source export date
2026-10-12
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:28

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS NOT FOR INJECTION OR INTRAVENOUS INFUSION. Do not use unless product is clear, seal is intact, vacuum is present and container is undamaged. Do not use if product is discolored or contains a precipitate. SINGLE patient use only. The contents of this bottle should not be used in more than one patient. This solution contains no preservative, unused contents should be discarded.

Adverse reactions cross-check#

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

adverse reactions

ADVERSE REACTIONS Irrigation or any other trauma may result in corneal swelling or bullous keratopathy. Post-operative inflammatory reactions as well as incidents of corneal edema and corneal decompensation have been reported.

Reported adverse events (FAERS/openFDA)#

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