FDA.reportPublic FDA data

FDA label cef6069f-0f1e-497b-9718-315ef734aa4f

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
f62000e3-e720-4283-8a00-a60f07747506
SPL ID
cef6069f-0f1e-497b-9718-315ef734aa4f
Version
1
Effective date
2021-06-21
Source export date
2026-11-06
Source partition
11
Source file
https://download.open.fda.gov/drug/label/drug-label-0011-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-11-06/3744b3ae389d13e8f30cade845ea29e0fc75bb043dcda980c2025693f0c10522/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
8dff71fbef1291eb7711013e9a3a06194930757924a8946ae3034107a98d9463
Import run
20261106T075659Z
Imported at
2026-11-06 09:04:45

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 • Do not use on broken skin or large areas of skin • Apply only to areas with acne • Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time • If irritation occurs, only use one topical acne medication at a time • Stop use and ask a doctor if skin irritation occurs or gets worse • Rinse right away with water if product gets in eyes Keep out of reach of children. If swallowed, get medical help or call a Poison Control Center right away.

Reported adverse events (FAERS/openFDA)#

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