FDA.reportPublic FDA data

FDA label 9ec8c3c5-c3b5-4c1a-aadb-1cb315898d38

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
b15e7405-5e88-4c38-9449-8511f5640b98
SPL ID
9ec8c3c5-c3b5-4c1a-aadb-1cb315898d38
Version
2
Effective date
2023-06-21
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:38:38

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. When using this product avoid contact with eyes. In case of eye contact, flush eyes with water. Ask a doctor: Stop use and consult a doctor if irritation or redness develops. If condition persists for more than 72 hours, discontinue use. Do not use on children less than 2 months of age or on open skin wounds. 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.