FDA.reportPublic FDA data

FDA label 197d15d8-e7b7-4013-a806-c1608c421949

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
1a8640de-e2bb-48e5-b664-e0c157a2337d
SPL ID
197d15d8-e7b7-4013-a806-c1608c421949
Version
2
Effective date
2010-09-01
Source export date
2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:49:35

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 use • if solution changes color or becomes cloudy • if single-use dispenser is not intact When using this product • do not touch tip of container to any surface to avoid contamination • do not reuse • once applied, discard Stop use and ask a doctor if • you experience eye pain, changes in vision, continued redness or irritation of the eye • condition worsens or persists for more than 72 hours Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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