FDA.reportPublic FDA data

FDA label d57c21a5-c79a-0c91-e053-2a95a90a045c

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
a61f807e-5c51-023f-e053-2995a90a5b9c
SPL ID
d57c21a5-c79a-0c91-e053-2a95a90a045c
Version
2
Effective date
2022-01-13
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:03:00

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 per1oration (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 earwax remains after use of this product. Keep out of reach of children if swallowed, get medical help or contact a Poison Control Center immediately.

Reported adverse events (FAERS/openFDA)#

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