FDA.reportPublic FDA data

FDA label 364c8795-31b7-cb2e-e063-6394a90a9d82

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
04cd8bf5-9758-8d87-e063-6394a90afbb7
SPL ID
364c8795-31b7-cb2e-e063-6394a90a9d82
Version
2
Effective date
2025-05-29
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:04:46

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 use in ears only. Do not use if you have ear tubes, a damaged eardrum, or after surgery Stop use and ask your doctor if symptoms persist for more than 48 hours or worsen symptoms are accompanied by a fever any discharge from the ear is present If pregnant or breatfeeding, seek professional advice before taking this product. Keep out of the reach of children. In case of accidental overdose, 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.