FDA.reportPublic FDA data

FDA label 0d583203-0b16-4858-8463-5966538f4413

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
b9c7f5c9-8570-4f5a-bf61-6abc5c4cc318
SPL ID
0d583203-0b16-4858-8463-5966538f4413
Version
2
Effective date
2015-11-11
Source export date
2026-10-12
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:00:58

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 Flammable keep away from sparks, heat and fire. Cap tube tightly when not in use. When using this product Avoid contact with the eyes Do not put in rectum Do not exceed recommended dosage unless directed by a doctor Stop use and ask a doctor if allergic reaction occurs condition worsens or does not improve within 7 days Symptoms clear up and return within a few days rectal bleeding occurs redness irritation, swelling, pain or other symptoms develop or increase

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.