FDA.reportPublic FDA data

FDA label e04513ed-8659-4749-9ca7-12c4459c3316

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
88868c00-cbdd-44b0-9e4d-b49efef54e09
SPL ID
e04513ed-8659-4749-9ca7-12c4459c3316
Version
4
Effective date
2016-09-23
Source export date
2026-10-12
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/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:48:34

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: Do not use in the eyes. Do not take internally by mouth Initial exacerbation may occur. The preparation must not be used if there is any damage to the ear drum, do not use with ear tubes. This product does not treat ear aches caused by an ear infection. Ear infections must be treated by a physician and proper medication that must be prescribed by a physician. If ear infections are not treated properly then may cause loss of hearing and deafness. Use only if bottle seal in intact.

Reported adverse events (FAERS/openFDA)#

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