FDA.reportPublic FDA data

FDA label fa3678af-6f05-4d1e-a307-96766c73bac0

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
4b8e9761-4312-4478-9a79-96e6515b018a
SPL ID
fa3678af-6f05-4d1e-a307-96766c73bac0
Version
2
Effective date
2018-03-13
Source export date
2026-10-12
Source partition
5
Source file
https://download.open.fda.gov/drug/label/drug-label-0005-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/13cbfcd236c665f0ee69e2d9141331148dcdff45d1679c92f029cfba27dd74a2/drug-label-0005-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:42:46

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 • over large areas of the body • longer that 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 • serious burns Stop use and ask a doctor if • condition persists or get worse • sore mouth symptoms do not improve in 7 days • irritation, pain or redness persists or worsend • swelling, rash or fever develops Keep out of reach of the children . Incase of accidental ingestion, seek professional assistance or contact a Poison Control Center right away

Reported adverse events (FAERS/openFDA)#

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