FDA label f546bbbf-a2e3-21f9-e053-2a95a90a1016

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
467bad22-2fd7-4009-907e-165168607882
SPL ID
f546bbbf-a2e3-21f9-e053-2a95a90a1016
Version
2
Effective date
2023-02-22
Source export date
2026-09-28
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/bb1af06e95bcf9567b07e56fcf3a03c0cac3c7c82ff89d4c970881174949e5b7/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:43:23

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 external use only, do not inject. Do not use if seal is broken or missing in case of ear infection, eardrum perforation, or if there is a foreign body in the ear without consulting physician in case of any type of earache

Reported adverse events (FAERS/openFDA)#

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