FDA.reportPublic FDA data

FDA label 6767c19e-afb9-45a4-99a6-7a884b6c7d34

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
5ff7ca0b-ce95-47e5-bccc-1c69a6cb506a
SPL ID
6767c19e-afb9-45a4-99a6-7a884b6c7d34
Version
5
Effective date
2018-07-24
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 05:39:43

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.