FDA.reportPublic FDA data

FDA label ff12c27f-d8dc-4fa2-9a19-c216f18fea6f

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
f354334d-9bc7-4d2a-bb72-a5e6d6de24f3
SPL ID
ff12c27f-d8dc-4fa2-9a19-c216f18fea6f
Version
2
Effective date
2011-04-06
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 06:22:36

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

For use in the ear only Do not use if you have • ear drainage or discharge • ear pain or irritation • rash in the ear • dizziness Ask a doctor before use • if you have an injury or a hole in the eardrum • after ear surgery When using this product • avoid contact with eyes Stop use and ask a doctor if • excessive earwax remains after 4 days' use Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away. • If product gets in eyes, flush with water. Call a doctor.

Reported adverse events (FAERS/openFDA)#

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