FDA.reportPublic FDA data

FDA label b1964630-68b1-4a41-ab6a-ed7f55d1f8b2

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
d3f80d9b-dc52-4043-a537-ab9b9665ac0f
SPL ID
b1964630-68b1-4a41-ab6a-ed7f55d1f8b2
Version
2
Effective date
2020-09-03
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:50:57

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 flames Do not use • In children less than 2 months of age • On open skin wounds. 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 redness develops. 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.