FDA.reportPublic FDA data

FDA label f0400de6-da34-4200-b18a-83cb086b4072

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
80d9f85b-ed0a-419a-999a-e750dc3f2718
SPL ID
f0400de6-da34-4200-b18a-83cb086b4072
Version
2
Effective date
2023-03-31
Source export date
2026-10-12
Source partition
7
Source file
https://download.open.fda.gov/drug/label/drug-label-0007-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/ff22b88bd32e56cbc369af80345075227138a42b1b3ba9a84f038fd5493a7a47/drug-label-0007-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:53:24

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: Flammable. Keep away from fire or flame. For external use only. Do not use • In Children less than 2 months of age • on open skin 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.