Home FDA labels 7ffbc527-f50e-42fd-9cd5-8d1caf5ea53f FDA label 7ffbc527-f50e-42fd-9cd5-8d1caf5ea53f 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 c9d03a52-8696-4965-996b-67c057a4f578
SPL ID 7ffbc527-f50e-42fd-9cd5-8d1caf5ea53f
Version 4
Effective date 2020-12-11
Source export date 2026-10-12
Source partition 5
Source file https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 01:41:26 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 WARNINGS: Do not use on children under 2 years of age unless directed by a physician. For external use only. Avoid contact with eyes. If irritation occurs or if there is no improvement within 4 weeks, discontinue use and consult a physician.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.