Home FDA labels a083527c-1a13-4745-b798-4039600ee12e FDA label a083527c-1a13-4745-b798-4039600ee12e 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 eb396317-4e5d-49d4-b17f-fb78d608dbd2
SPL ID a083527c-1a13-4745-b798-4039600ee12e
Version 1
Effective date 2017-12-15
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 01:26:10 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 institutionaal and professional use only.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.