FDA label 5cbeacb6-e128-45e7-bb60-12bec70ce3b4

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
e9f63585-0f48-4ec0-9861-e9c5782cec60
SPL ID
5cbeacb6-e128-45e7-bb60-12bec70ce3b4
Version
3
Effective date
2017-12-01
Source export date
2026-09-28
Source partition
9
Source file
https://download.open.fda.gov/drug/label/drug-label-0009-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/6784607726c827491ceaeab30d843632e0660ee8008c535197be5ed9e1e52201/drug-label-0009-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:01:22

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 If pregnant or breastfeeding consult a healthcare professional before use. Do not use on children 2 years of age unless directed by a doctor. When using this product avoid contact with eyes Use only as directed by a doctor on persons with highly sensitive skin. Stop use and consult a doctor if there is no improvement within 4 weeks irritation occurs Keep out of children. If accidental ingestion occurs, 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.