Home FDA labels c7554597-7b28-4df3-8ec3-34a0dd72cfeb FDA label c7554597-7b28-4df3-8ec3-34a0dd72cfeb 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 b5386a41-3d0e-4127-aee3-a9ee6eaadc7b
SPL ID c7554597-7b28-4df3-8ec3-34a0dd72cfeb
Version 1
Effective date 2016-12-01
Source export date 2026-10-12
Source partition 8
Source file https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/fa098e7c5cff0b1ab653ce934059d1f4b90b860bafc0383a1f66223ce1037518/drug-label-0008-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:06:57 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.
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 in eyes. Discontinue use if irritation and redness develop. If condition persists for more than 72 hours, consult a physician. Not for use on children under six months of age. For institutional and professional use only.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.