FDA label 08385d6c-6e21-4d5f-8aaf-da65ec99e079

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
e76e95d0-e666-48c4-8ec4-a65215bf8512
SPL ID
08385d6c-6e21-4d5f-8aaf-da65ec99e079
Version
2
Effective date
2019-11-05
Source export date
2026-11-06
Source partition
8
Source file
https://download.open.fda.gov/drug/label/drug-label-0008-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/db89d5ebfc3e02f44e8769334d799cd3436b05f779823ab00297f1f800c89ddf/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 07:30:46

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 you are allergic or sensitive to any of the ingredients listed. When using this product avoid contact in or near eyes and mouth (oral mucosa). In case of eye contact, flush eyes with water. Stop use and ask a doctor if irritation, rash or other allergic reaction develops.

Reported adverse events (FAERS/openFDA)#

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