FDA label ed7fbc53-91ca-4497-8d10-78beb9fa1ccd

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: 77df2c88-3ec3-4eff-b381-3173c2dc0612
SPL ID: ed7fbc53-91ca-4497-8d10-78beb9fa1ccd
Version: 6
Effective date: 2020-05-08
Source export date: 2026-08-17
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/2026-08-17/559e90e291f706011ac4a15e81427bf26ca36e5d0b9d84e84d297d7c5834404b/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: ca19d5b1416b6b66a9d383bfdc77d90e91adfeefe16ffcc1ac6b06ceb90d8d73
Import run: 20260818T065550Z
Imported at: 2026-08-18 07:01:11

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		ed7fbc53-91ca-4497-8d10-78beb9fa1ccd	id
spl set id		77df2c88-3ec3-4eff-b381-3173c2dc0612	set_id

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 topical ophthalmic use only. Not for parenteral use. Not for injection. Do not use solution if it contains crystals or if it is cloudy or discolored. Prolonged use results in diminished duration of anesthesia and retarded healing. This may cause the drug to be used more frequently, creating a "vicious circle". Subsequent corneal infection and/or corneal opacification with accompanying permanent visual loss or corneal perforation may occur. Prolonged use may also product severe keratitis.

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: Transient symptoms (signs) such as stinging, burning, and conjunctival redness may occur. A rare, severe, immediate type allergic corneal reaction has been reported characterized by acute diffuse epithelial keratitis with filament formation and/or sloughing of large areas of necrotic epithelium, diffuse stromal edema, descemetitis and iritis. To report SUSPECED ADVERSE REACTIONS, contact OCuSOFT, Inc. at 800-239-5469, www.ocusoft.com