FDA label 394ec837-7cc2-4dd6-a463-6ba1d565c8e0

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: 8007e373-70c0-4dfe-a0a8-59a3704b56ea
SPL ID: 394ec837-7cc2-4dd6-a463-6ba1d565c8e0
Version: 1
Effective date: 2012-10-25
Source export date: 2026-10-12
Source partition: 3
Source file: https://download.open.fda.gov/drug/label/drug-label-0003-of-0014.json.zip
Source object key: raw/openfda/drug-label/2026-10-12/f40eac55ff4c5d55c3d8bbc5766ea7e21e4196960cfb4703b96a406b491c0cd5/drug-label-0003-of-0014.json.zip
Source manifest SHA-256: 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run: 20261013T011858Z
Imported at: 2026-10-13 01:34:46

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		394ec837-7cc2-4dd6-a463-6ba1d565c8e0	id
spl set id		8007e373-70c0-4dfe-a0a8-59a3704b56ea	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. WHEN USING THIS PRODUCT DO NOT GET INTO EYES. IF CONTACT OCCURS, RINSE EYES THOROUGHLY WITH WATER. KEEP OUT OF REACH OF CHILDREN IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER IMMEDIATELY. STOP USING THIS PRODUCT AND ASK A DOCTOR IF IRRITATION OR REDNESS DEVELOPS AND LASTS.

Reported adverse events (FAERS/openFDA)#

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