FDA.reportPublic FDA data

FDA label 2035bfab-4915-0e91-e063-6294a90a7b22

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
c8265b99-3df9-42c6-e053-2995a90a2a2d
SPL ID
2035bfab-4915-0e91-e063-6294a90a7b22
Version
2
Effective date
2024-08-21
Source export date
2026-09-28
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/2026-09-28/ae3816359e336a5de4f44607730a3d12ceb61ffa012a132189ceda22541b38ee/drug-label-0008-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:53:24

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 on Children - under 12 years old of age unless directed by a physician. Do not use on children - under 12 years of age unless directed by a physician. Some users of this product may experience a mild skin irritation. If skin irritation becomes severe, stop use and consult a doctor. Keep out of eyes. Rinse water to remove. 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.