FDA.reportPublic FDA data

FDA label 828dd539-9ef9-4bce-9a5d-c67cf686d4df

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
31dcfdcf-0190-416e-97b4-b5b04418058f
SPL ID
828dd539-9ef9-4bce-9a5d-c67cf686d4df
Version
1
Effective date
2012-12-07
Source export date
2026-11-06
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/2026-11-06/2233cb6af8c6b55a5e4a05449e8db0d2f259f3c061d5d001b654a8bea1cc1db2/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:56:50

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 in the eyes. Initial exacerbation may occur. Ask a doctor before use if you have: ear drainage or discharge pain, irritation, or rash in the ear had ear surgery dizziness Stop use and ask a doctor if: irritation (too much burning) or pain occurs symptoms persist for more than 48 hours If pregnant or breast feeding, ask a health professional before use. 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.