FDA label 3e8ab933-99be-bfee-e063-6294a90a48cd

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
09d100e8-5e04-4a96-acbd-1bd5141ecebe
SPL ID
3e8ab933-99be-bfee-e063-6294a90a48cd
Version
3
Effective date
2025-09-11
Source export date
2026-10-12
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/2026-10-12/a497e765d824a2e2aa9e88d5f0eea2aae9dcba363989e5f163395cda5c3c9dd8/drug-label-0011-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:42:18

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 Skin irritattion and dryness if 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. Do not use on broken skin. When using this product Apply only to areas with acne. If excessive skin irritation develops or increases, discontinue use and consult a doctor. Avoid contact with eyes and mouth. Keep out of reach of children. If 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.