FDA.reportPublic FDA data

FDA label 64b7d539-7a5d-aed4-e053-2991aa0a627c

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
837a3726-8582-4c72-a949-82378b93262f
SPL ID
64b7d539-7a5d-aed4-e053-2991aa0a627c
Version
2
Effective date
2018-02-08
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 05:59:28

Boxed warning cross-check#

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

Boxed warning sections page 1 of 1 · 1 matching rows.

boxed warning

Back Panel - Warnings Warnings For external use only. ---------------------------------------------------------- Do not use on damaged or broken skin ---------------------------------------------------------- When using this product keep out of eyes. Rinse with water to remove. ----------------------------------------------------------- Stop use and ask doctor if rash occurs ---------------------------------------------------------- Keep out of reach of children. If product is 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.