FDA.reportPublic FDA data

FDA label 5b4c09e6-4228-47d5-b8f2-5959f8aede38

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
5b4c09e6-4228-47d5-b8f2-5959f8aede38
SPL ID
5b4c09e6-4228-47d5-b8f2-5959f8aede38
Version
1
Effective date
2011-02-15
Source export date
2026-10-12
Source partition
2
Source file
https://download.open.fda.gov/drug/label/drug-label-0002-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/4760f38f2bcb10aa20ddbadb42b270d31e9f2a8024440d3af3dec8d11feb92ec/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:29:33

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 Use only as directed. If pain persists more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult your physician immediately. Discontinue use if excessive irritation of the skin develops. Avoid getting into the eyes or on mucous membranes. For external use only. Use only as directed. Do not apply to wounds, broken or irritated skin. Do not use with a heating pad. Do not bandage tightly. If swallowed, induce vomiting and contact a physician or poison control center immediately.

Reported adverse events (FAERS/openFDA)#

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