FDA label cee3e941-cdfe-40f7-95ec-959fcafdcd28

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
2291fb2b-2daa-40a9-ab36-52a990dc95f4
SPL ID
cee3e941-cdfe-40f7-95ec-959fcafdcd28
Version
1
Effective date
2025-10-30
Source export date
2026-09-28
Source partition
3
Source file
https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/fd09911bd1bc81f7f2faeb048e63855fe224e494376ae919a0035190e315c050/drug-label-0003-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:18:39

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 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.