FDA.reportPublic FDA data

FDA label f58aea4b-0f36-4fef-90d6-bebee1593749

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
587095fc-fabe-4dda-ab93-b1a3e9a8b078
SPL ID
f58aea4b-0f36-4fef-90d6-bebee1593749
Version
4
Effective date
2013-08-21
Source export date
2026-09-28
Source partition
6
Source file
https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:41:47

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 Ask a doctor before use if you have • ear drainage or discharge • irritation or rash in the ear • an injury or perforation (hole) of the eardrum • recently had ear surgery • ear pain • dizziness When using this product avoid contact with the eyes Stop use and ask a doctor if • you need to use for more than four days • excessive earwax remains after use of this product Keep this and all drugs out of the 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.