FDA label b13162b0-474f-4028-94c4-6a9a27b583fb

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: 9f9d2211-0fe9-44c0-9b41-5f12ae4f9b87
SPL ID: b13162b0-474f-4028-94c4-6a9a27b583fb
Version: 2
Effective date: 2021-12-09
Source export date: 2026-10-12
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/2026-10-12/b25dad4aaef9c88f0e827394a34fbbd1ce7d71422fa46b5d1e123befad498c1d/drug-label-0006-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:52:19

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		b13162b0-474f-4028-94c4-6a9a27b583fb	id
spl set id		9f9d2211-0fe9-44c0-9b41-5f12ae4f9b87	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 FREEZE. FOR EXTERNAL USE ONLY. DO NOT USE IN EARS, EYES OR MOUTH. IN CASE OF CONTACT WITH EYES, FLUSH EYES WITH WATER. - STOP USE AND SEEK MEDICAL ADVICE IF REDNESS OR IRRITATION DEVELOP AND PERSIST FOR MORE THAN 72 HOURS. KEEP OUT OF REACH OF CHILDREN. CHILDREN UNDER 6 YEARS OF AGE MUST BE SUPERVISED WHEN USING THIS PRODUCT.

Reported adverse events (FAERS/openFDA)#

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