FDA label c135a17b-8109-4cc9-e053-2a95a90a4e13
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
- SPL set ID
- 76e30658-9d34-e0df-e053-2a91aa0a855d
- SPL ID
- c135a17b-8109-4cc9-e053-2a95a90a4e13
- Version
- 5
- Effective date
- 2021-04-30
- Source export date
- 2026-11-06
- 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/2026-11-06/d05434af5edc4383b7c7894a8f2d94df21171d17714450933cecdfc35cedfa3d/drug-label-0001-of-0014.json.zip
- Source manifest SHA-256
- 4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
- Import run
- 20261108T063105Z
- Imported at
- 2026-11-08 06:44:13
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | c135a17b-8109-4cc9-e053-2a95a90a4e13 | id | |
| spl set id | 76e30658-9d34-e0df-e053-2a91aa0a855d | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
WARNINGS: 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.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
ADVERSE REACTIONS: Transient symptoms (signs) such as stinging, burning and conjunctival redness may occur. A rare, severe, immediate allergic cornea 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.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.