FDA label faf79d2a-fede-4408-b31a-ccfe13fde47f

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
1a1523f0-9d65-44de-afab-a0df6faebb8a
SPL ID
faf79d2a-fede-4408-b31a-ccfe13fde47f
Version
2
Effective date
2025-04-16
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:03:39

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 . Do Not Use • if you have ear drainage or discharge, ear pain, irritation or rash in the ear, or are dizzy; consult 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 four consecutive days. When using this product avoid contact with the eyes Stop use and ask a doctor if excessive ear wax remains after use of this product for four 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.