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
2026-08-01
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/2026-08-01/286b06ef66f7efdb8cdf48688678b429950d1b94558fe44fcd6cc6eb20c2100b/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
bdd1454d0606b622b70458a306b8a10d8a8787db06fd9f46e69c7f7a4524b630
Import run
20260801T225920Z
Imported at
2026-08-01 23:04:12

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.