Home FDA labels 438f6b9e-8c91-0637-e054-00144ff88e88 FDA label 438f6b9e-8c91-0637-e054-00144ff88e88 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 2c20f46f-4dc6-45f5-934c-7f924b35c854
SPL ID 438f6b9e-8c91-0637-e054-00144ff88e88
Version 4
Effective date 2016-12-13
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 01:25:35
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 on damaged or broken skin. Stop use and ask a doctor if rash occurs When using this product keep out of eyes. Rinse with water and remove. Keep out of reach of children. If swallowed, get medical help or contact a Poison Center right away.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.