FDA label 5738737e-d402-6937-e063-6394a90a0a5c

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: 53d898b4-91e9-2838-e063-6294a90a4ed2
SPL ID: 5738737e-d402-6937-e063-6394a90a0a5c
Version: 2
Effective date: 2026-07-22
Source export date: 2026-10-12
Source partition: 4
Source file: https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:39:36

Harmonized identifier links#

Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.

Harmonized identifiers page 1 of 1 · 2 matching rows.

Type, Scope, Identifier table
Type	Scope	Identifier	Source field
spl id		5738737e-d402-6937-e063-6394a90a0a5c	id
spl set id		53d898b4-91e9-2838-e063-6294a90a4ed2	set_id

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 eardrum is perforated. For use in the ear only. Tip of the applicator should never enter the ear canal. Ask a doctor before use if you have ear drainage or discharge, ear pain, irritation, or rash in the ear. When using this product avoid contact with the eyes. Keep out of reach of children. In case of accidental ingestion, contact a poison control center immediately. Do not use if the tamper band is broken or missing.

Reported adverse events (FAERS/openFDA)#

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