FDA.reportPublic FDA data

FDA label d886a2f0-e84f-cc6e-f67d-bd11656371cb

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
d2f55b3f-0873-4536-aedb-2829a91927c7
SPL ID
d886a2f0-e84f-cc6e-f67d-bd11656371cb
Version
2
Effective date
2016-01-28
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:22:10

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.