FDA.reportPublic FDA data

Systane ULTRA

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)

Brand name
Systane ULTRA
Generic name
POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL
Manufacturer
Alcon Laboratories, Inc.
Product type
HUMAN OTC DRUG
SPL set ID
a5c1c194-3db5-4f18-9cd1-97f7f84c3cff
SPL ID
cce3e663-58ef-4ece-a6d2-c49ecc7ea9cb
Version
15
Effective date
2023-12-15
Source export date
2026-08-01
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-08-01/0689a4374f1490600b5244071db3b04bd3bbc29ceda7a856edb8225323adf20a/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:00:58
Harmonized routes table
Harmonized routes
OPHTHALMIC

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 For external use only. Do not use if this product changes color or becomes cloudy if you are sensitive to any ingredient in this product When using this product do not touch tip of container to any surface to avoid contamination do not reuse once opened, discard Stop use and ask a doctor if you experience any of the following: 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.