FDA.reportPublic FDA data

FDA label b34a15f4-294e-45e5-85a2-633140f70537

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
bea9a1a9-29be-4178-a65c-fbcb174801ae
SPL ID
b34a15f4-294e-45e5-85a2-633140f70537
Version
3
Effective date
2020-06-30
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 01:29:09

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 2 · 5 matching rows.

warnings

Warnings When using this product do not get into eyes Stop use and ask a doctor if condition worsens symptoms last more than 7 days or clear up and occur again within a few days Keep out of reach of children. If more than used for lip protection is accidentally swallowed, get medical help or contact a Poison Control Center right away.

warnings

Warnings For external use only. Stop use and ask a doctor if condition last more than 7 days

warnings

Warnings For external use only. Stop use and ask a doctor if condition last more than 7 days

warnings

Warnings For external use only. Stop use and ask a doctor if condition last more than 7 days

Reported adverse events (FAERS/openFDA)#

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