FDA label b9ae6a78-722a-4f29-e053-2995a90a9563

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: 93ca388d-350b-3a17-e053-2995a90a037b
SPL ID: b9ae6a78-722a-4f29-e053-2995a90a9563
Version: 4
Effective date: 2021-01-24
Source export date: 2026-09-28
Source partition: 6
Source file: https://download.open.fda.gov/drug/label/drug-label-0006-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-09-28/e0861bcde1444ef952820955caafc6f3fd29783e5ade07a13d933aa3336b399f/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run: 20260929T050834Z
Imported at: 2026-09-29 05:40:46

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		b9ae6a78-722a-4f29-e053-2995a90a9563	id
spl set id		93ca388d-350b-3a17-e053-2995a90a037b	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 For external use only. Do not use if you are allergic to any of our ingredients in your ears, mouth, or eyes. If eye contact occurs, rinse thoroughly with water. Ask a doctor before use if you have open wounds. serious burns. Stop use and ask doctor if redness or skin irritation develop after use, and persists for more than 72 hours. Keep out of reach of children Children should be supervised when using this product.

Reported adverse events (FAERS/openFDA)#

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