FDA label 21092699-6ba7-42d2-b148-66a669084bc6

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
21092699-6ba7-42d2-b148-66a669084bc6
SPL ID
21092699-6ba7-42d2-b148-66a669084bc6
Version
1
Effective date
2010-11-04
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:48:10

Warnings cross-check#

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Warnings sections page 1 of 1 · 1 matching rows.

warnings

WARNINGS: NOT FOR INJECTION INTO EYE - FOR TOPICAL USE ONLY Employment of steroid medication in the treatment of herpes simplex keratitis involving the stroma requires great caution; frequent slit-lamp microscopy is mandatory. Prolonged use may result in elevated intraocular pressure and/or glaucoma, damage to the optic nerve, defects in visual acuity and fields of vision, posterior subcapsular cataract formation, or may aid in the establishment of secondary ocular infections from pathogens liberated from ocular tissues. In those diseases causing thinning of the cornea or sclera, perforation has been known to occur with the use of topical steroids. Acute purulent untreated infection of the eye may be masked or activity enhanced by presence of steroid medication. Viral, bacterial, and fungal infections of the cornea may be exacerbated by the application of steroids. This drug is not effective in mustard gas keratitis and Sjögren’s keratoconjuncitivitis. If irritation persists or develops, the patient should be advised to discontinue use and consult prescribing physician.

Adverse reactions cross-check#

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adverse reactions

ADVERSE REACTIONS: Glaucoma with optic nerve damage, visual acuity and field defects, posterior subcapsular cataract formation, secondary ocular infections from pathogens including herpes simplex and fungi, and perforation of the globe. Rarely, filtering blebs have been reported when topical steroids have been used following cataract surgery. Rarely, stinging, or burning may occur.

Reported adverse events (FAERS/openFDA)#

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