Home FDA labels 553daa05-a567-42ee-8045-8f52741b4cbb FDA label 553daa05-a567-42ee-8045-8f52741b4cbb 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 2b3fc4ab-c8f4-489f-8523-defd3a1b12f0
SPL ID 553daa05-a567-42ee-8045-8f52741b4cbb
Version 3
Effective date 2018-12-24
Source export date 2026-10-12
Source partition 9
Source file https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key raw/openfda/drug-label/2026-10-12/fb14b8f3d34b45230a84f851c029385f512adf3f002423a9b78d4f7ca626ecec/drug-label-0009-of-0014.json.zip
Source manifest SHA-256 7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run 20261013T011858Z
Imported at 2026-10-13 02:23:37 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 •Avoid contact with the eyes Consult a doctor • If condition worsens or does not improve within 7 days • In case of bleeding • Before exceeding the recommended dosage DO NOT put this product into the rectum using fingers or any mechanical device.
Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.