FDA.reportPublic FDA data

FDA label 84079171-cbd5-473a-8a92-b870e8a681b3

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
57f21b4e-a012-4c93-9468-dfb622f15d02
SPL ID
84079171-cbd5-473a-8a92-b870e8a681b3
Version
4
Effective date
2019-09-05
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:34:48

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 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.