FDA.reportPublic FDA data

FDA label 763250f2-0ac4-4518-a6b7-2d5aa90da288

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
e1dacadf-cfb4-4a06-9858-dd6fba2975f8
SPL ID
763250f2-0ac4-4518-a6b7-2d5aa90da288
Version
5
Effective date
2025-05-01
Source export date
2026-10-12
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:18:39

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 • ear pain • irritation or rash in the ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery 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 (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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