FDA label a488ed1b-4775-4bdd-9a37-13841e2206e6

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
c91f328f-c9d7-48ce-8453-fa47adc53262
SPL ID
a488ed1b-4775-4bdd-9a37-13841e2206e6
Version
3
Effective date
2020-01-18
Source export date
2026-10-12
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/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:59:24

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

Warnings For external use only Do not use this product for more than 4 days Ask a doctor before use if you have ear drainage or discharge, ear pain, irritation, a rash in the ear or are dizzy if you have an injury or perforation (hole) of the eardrum or after ear surgery When using this product avoid contact with the eyes Stop use and ask a doctor if excessive ear wax remains after 4-day treatment with this product Never insert cotton swabs, toothpicks, hairpins or other objects into the ear canal to remove earwax. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) 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.