FDA label 663bae1b-c8e4-104a-e053-2991aa0a4edf

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: 663bae1b-c8e3-104a-e053-2991aa0a4edf
SPL ID: 663bae1b-c8e4-104a-e053-2991aa0a4edf
Version: 1
Effective date: 2016-03-09
Source export date: 2026-09-28
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/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 06:31:51

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		663bae1b-c8e4-104a-e053-2991aa0a4edf	id
spl set id		663bae1b-c8e3-104a-e053-2991aa0a4edf	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 Ask a doctor before use if you have ear drainage or discharge Ear pain Irritation or rash in the ear Dizziness An injury or perforation (hole) in the eardrum Recently had ear surgery Whe using this product avoid contact with the eyes. Stop use and ask a doctor if You need to use it for more than 3 days in a row.

Reported adverse events (FAERS/openFDA)#

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