FDA.reportPublic FDA data

FDA label b09edaad-3114-2716-e053-2995a90a8bff

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
b09ee149-2872-6b99-e053-2995a90a84d5
SPL ID
b09edaad-3114-2716-e053-2995a90a8bff
Version
1
Effective date
2020-10-01
Source export date
2026-10-30
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-30/772d0e4623a189b47f3ab71d7d51f9b3c89c5526f4cf3d218e1c921bb964b80c/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
b11f1f6b476c7417db937215bf14307ef1a0b69465b42b411ad52f42ae36ead3
Import run
20261102T182004Z
Imported at
2026-11-02 18:28:08

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 fire or flame. Do not use On open skin wounds In children less than 2 months of age When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water. Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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