FDA.reportPublic FDA data

FDA label 0aa71de4-c39f-44da-a66e-0e10722085e8

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
64fbcb2f-8d48-477d-a896-72e12c9af08b
SPL ID
0aa71de4-c39f-44da-a66e-0e10722085e8
Version
2
Effective date
2018-12-12
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 01:29:28

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. Do not use in the eyes or apply over large areas of the body longer than one week on deep or puncture wounds, animal bites, or on serious burns Ask a doctor before use if you have deep or puncture wounds, animal bites or serious burns Stop use and ask a doctor if the condition persists or gets worse sore mouth symptoms do not improve in 7 days irritation, pain or redness persists or worsens swelling, rash or fever develops Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Reported adverse events (FAERS/openFDA)#

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