FDA.reportPublic FDA data

FDA label 364cb195-06ca-102a-e063-6294a90ab863

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
677c111f-513b-4148-a954-2a801fa4ebcf
SPL ID
364cb195-06ca-102a-e063-6294a90ab863
Version
4
Effective date
2025-05-29
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 23:04:07

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 ears only. Do not use if you have: ear drainage, discharge, dizziness, ear tubes, damaged ear drum, or fever of 102 or greater. Consult a physician before use: if pregnant or breastfeeding, in children under 2 years of age. Stop use and ask your doctor: if symptoms worsen, reoccur, or persist for more than 48 hours, or if fever develops. Keep out of the reach of children Do not use if neckband is missing or broken