FDA.reportPublic FDA data

FDA label b8c7c411-edd8-11a4-e053-2a95a90a9326

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
12b1ba5c-2b5a-42c5-9f76-b57c9a9a5380
SPL ID
b8c7c411-edd8-11a4-e053-2a95a90a9326
Version
1
Effective date
2021-01-13
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 01:29:23

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 . Not for use on open wounds. • If symptoms persist or worsen, discontinue use, seek medical attention. • Avoid contact with eyes. If product gets into eyes, flush with water, seek medical attention. • If rash, redness, irritation or itching occurs, discontinue use. • If pregnant or breastfeeding ask a health professional before use. • If diagnosed with psychiatric or mood disorder, seek medical advice before use. • If swallowed, get medical help or contact a Poison Center. • Keep out of reach of children.

Reported adverse events (FAERS/openFDA)#

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