FDA.reportPublic FDA data

FDA label 328d778c-aeab-5af1-e063-6394a90ad8bd

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
328d778c-aeaa-5af1-e063-6394a90ad8bd
SPL ID
328d778c-aeab-5af1-e063-6394a90ad8bd
Version
1
Effective date
2025-04-11
Source export date
2026-11-06
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/2026-11-06/4dafeb36642dffb72e2138939a956de402f722ea8c14c08cd87068efd3669f01/drug-label-0002-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 06:49:19

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● on children under 2 years of age unless directed by a doctor. Stop use and ask a doctor ●if irritation occurs or if there is no improvement within 4 weeks. When using this product●Possible side effects may include mild skin irritation, redness, or itching at the application site. Discontinue use and consult a doctor if severe reactions(e.g., swelling, rash) occur. Keep out of reach of children. If swallowed,get medical help or contacta Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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