FDA label 391897b2-7553-4c30-b756-9ac7e7b18e27

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: 32bf8ffa-c495-434a-be87-b158998ab379
SPL ID: 391897b2-7553-4c30-b756-9ac7e7b18e27
Version: 2
Effective date: 2014-05-24
Source export date: 2026-10-12
Source partition: 1
Source file: https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/7928c8e8c6256620071a8b7e5b93eb8dfa543649c08d17a01ea02251012ba58c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:25:44

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		391897b2-7553-4c30-b756-9ac7e7b18e27	id
spl set id		32bf8ffa-c495-434a-be87-b158998ab379	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 Warning For External Use Only Do not use In the eye for more than 4 days Ask a doctor before use if you have ear drainage or discharge pain, irritation or rash in the ear had ear surgery an injury or perforation (hole) in the ear drum Stop use and ask a doctor if Stop use and ask a doctor if excessive earwax remains after use Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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