FDA.reportPublic FDA data

FDA label 2cdf6775-d49c-59db-e063-6394a90adeba

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
4229f02a-bd71-4d27-94d6-ae860bd60d20
SPL ID
2cdf6775-d49c-59db-e063-6394a90adeba
Version
4
Effective date
2025-01-29
Source export date
2026-10-12
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:31:39

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 2 matching rows.

warnings

Warnings For use in the ear only 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 When using this product • avoid contact with the eyes Stop use and ask a doctor if • you need to use for more than 4 days • excessive ear wax remains after use of this product Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center (800-222-1222) right away.

warnings

Warnings For use in the ear only 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 When using this product avoid contact with the eyes Stop use and ask a doctor if you need to use for more than 4 days excessive ear wax remains after use of this product Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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