FDA label 69160de9-3fc0-4e95-bcf9-0455230d5988

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
f18d11d7-e8cf-42a3-b618-f14f92d03289
SPL ID
69160de9-3fc0-4e95-bcf9-0455230d5988
Version
4
Effective date
2011-02-04
Source export date
2026-11-06
Source partition
13
Source file
https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/245ea1c0d730b312e4410f082201cbe2cb4d1936fa2918316b6ea631293cbeba/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
4a7570ba105b5a039a8e1c94a85e7f085b9047a8882a35a96bf1e4516c5ffc97
Import run
20261108T063105Z
Imported at
2026-11-08 08:06:13

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

From Warnings Section of Carton Label: Warnings For external use only. ______________________________ Ask a doctor before use on children under 2 years of age ____________________________________ When using this product avoid contact with the eyes ____________________________________ Stop use and consult a doctor if - Irritation occurs - you do not notice improvement within 4 weeks ____________________________________ KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN If accidental ingestion occurs, immediately contact a physician, emergency medical facility or Poison Control Center for help.

Reported adverse events (FAERS/openFDA)#

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