FDA.reportPublic FDA data

FDA label 7334f45e-5f8f-4072-93e7-2f907db8d2d5

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
628a60a0-fbb9-4d71-b5c2-dfba9edd67a3
SPL ID
7334f45e-5f8f-4072-93e7-2f907db8d2d5
Version
1
Effective date
2011-04-25
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:12:58

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 ear drum - recently had ear surgery Stop use and ask a doctor if - you need to use for more than four days - excessive wax remains after use of this product When using this product - avoid contact with the eyes 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.