FDA.reportPublic FDA data

FDA label 5cf21fab-2562-2573-e053-2991aa0a9d67

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
1108aa35-b9c2-0553-e054-00144ff88e88
SPL ID
5cf21fab-2562-2573-e053-2991aa0a9d67
Version
2
Effective date
2017-11-01
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:49:46

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 •Not for use on children under 2 years old except as directed by a pediatrician. •Avoid contact with eyes and mucous membranes. •Do not apply to large areas of the body and do not use for extended periods of time. •For external use only. •If irritation develops and persists, discontinue use and ask a doctor. •When using this product, if condition worsens or if symptoms persists for more than 7 days or clear up and occur again within a few days, stop use and ask a doctor.

Reported adverse events (FAERS/openFDA)#

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