FDA label d0d69ee3-f074-2666-e053-2a95a90a7206

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
d0d69ee3-f073-2666-e053-2a95a90a7206
SPL ID
d0d69ee3-f074-2666-e053-2a95a90a7206
Version
1
Effective date
2021-11-15
Source export date
2026-10-12
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:25:24

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

Ask doctor before use if you have • ear drainage or discharge • ear pain • irritation or rash in ear • dizziness • an injury or perforation (hole) of the eardrum • recently had ear surgery When using this product avoid contact with eyes Stop and ask doctor before use if • you need to use for more than four days • excessive earwax remains after use of this product Stop use and ask a doctor if ​you need to use for more than four days • excessive earwax remains after use of this product Keep out of reach of the children If product is swallowed, get medical help or contact a Poison Control Center right away

Reported adverse events (FAERS/openFDA)#

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