FDA label c61bac4c-d8e3-4709-ac11-213f626a88bf

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
156263bd-5a6f-47e4-afe4-c952f1044072
SPL ID
c61bac4c-d8e3-4709-ac11-213f626a88bf
Version
1
Effective date
2010-09-08
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:04:52

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:DO NOT ADMINISTER BALANCED SALT SOLUTIONS INTRAVENOUSLY. NOT FOR INJECTION.

Adverse reactions cross-check#

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

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

adverse reactions

ADVERSE REACTIONS: Bullous keratopathy may result when abnormal corneal endothelium is irrigated or subjected to any other trauma. There have been reports of corneal clouding and corneal edema following ocular surgery in which a balanced salt solution was used for irrigation. The frequency of such events has not been established adequately. Should any adverse reaction occur, discontinue use of this product, institute appropriate care, and save the remaining fluid for analysis.

Reported adverse events (FAERS/openFDA)#

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