FDA label 03dcd31c-2779-4787-8524-74e25a0ed711

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
433f9200-c77c-4746-96ce-13e40191060e
SPL ID
03dcd31c-2779-4787-8524-74e25a0ed711
Version
3
Effective date
2017-11-22
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:03:41

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 the ear only Do not use: • if you have ear drainage or discharge, ear pain, irritation, or rash in the ear or are dizzy; ask a doctor • if you have an injury or perforation (hole) of the eardrum or after ear surgery unless directed by a doctor • for more than 4 days When using this product avoid contact with the eyes. Stop use and ask a doctor if excessive earwax remains after use of this product for 4 consecutive days Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. If accidental contact with eyes occurs, flush eyes with water and consult a doctor.

Reported adverse events (FAERS/openFDA)#

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