FDA.reportPublic FDA data

FDA label 107b5a32-577f-4153-a28e-8d62b9568e69

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
7006b786-ec05-44b1-b5b2-be07bc2219da
SPL ID
107b5a32-577f-4153-a28e-8d62b9568e69
Version
5
Effective date
2020-11-10
Source export date
2026-09-28
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/663999d0fe1757c1e2cd13a4799d76d875f663e0bc57701092264ebe7febfc18/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:22:45

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 For use in the ear only Do not use this product, unless directed by a doctor • if you have an injury or perforation (hole) of the ear drum • after ear surgery • for more than 4 days Ask your doctor before use if you • have ear drainage or discharge • have ear pain, irritation or rash in the ear • feel dizzy When using this product avoid contact with the eyes Keep out of the reach of children. In case of accidental ingestion, 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.