FDA.reportPublic FDA data

FDA label 14923b5b-ad35-a041-e063-6294a90a8dca

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
14858e44-dfe0-318f-e063-6294a90a4421
SPL ID
14923b5b-ad35-a041-e063-6294a90a8dca
Version
2
Effective date
2024-03-26
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:23:49

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 ear wax remains after use this product Keep out of reach of children. In case of accidental overdose or allergic reaction, get medical help If swallowed, get medical help or contact a Poison Control Center immidiately.

Reported adverse events (FAERS/openFDA)#

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