FDA.reportPublic FDA data

FDA label b76b7589-8b6d-4767-8bf2-edc928a07804

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
5f5b6133-ac36-461a-983b-47c51b1474f4
SPL ID
b76b7589-8b6d-4767-8bf2-edc928a07804
Version
2
Effective date
2018-08-24
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:26

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 the ear only Do not use this product, unless directed by a doctor if you have an injury or perforation (hole) of the ear drum after ear surgery for more than 4 days Ask your doctor before use if you have ear drainage or discharge have ear pain, irritation or rash in the ear feel dizzy When using this product avoid contact with the eyes Keep out of the reach of children. In case of accidental ingestion, 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.