FDA.reportPublic FDA data

FDA label 8768f920-0de7-4774-8a2b-8fd3503c3561

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
e3be923e-dc02-4fab-918b-5e5dfb05b780
SPL ID
8768f920-0de7-4774-8a2b-8fd3503c3561
Version
3
Effective date
2015-10-28
Source export date
2026-10-12
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:48:40

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 - if pregnant or breastfeeding, consult physician prior to use - in large quantities, particularly over raw surfaces or blistered areas When using this product - use only as directed - do not bandage tightly - avoid contact with eyes - do not apply to open wounds or damaged skin Stop use and ask a doctor if - symptoms persist for more than seven days, discontinue use and consult physician - swallowed, consult physician Keep out of reach of children. Consult physician for children under 12

Reported adverse events (FAERS/openFDA)#

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