FDA label 78a583e8-898b-44e9-a7e0-526a2cc0ccba

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
03323ed2-d015-4284-b5b3-daebc5db4e16
SPL ID
78a583e8-898b-44e9-a7e0-526a2cc0ccba
Version
5
Effective date
2024-12-23
Source export date
2026-10-12
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/2026-10-12/b8dac220ac9fc8ffb4d86c6e00ece30169fc4575ca0cc92e5c9ce1a524fb0249/drug-label-0013-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 03:09:13

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

Warnings For external use only Do not use if you Have very sensitive skin Are sensitive to benzoyl peroxide When using this product 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. Avoid unnecessary sun exposure and use a sunscreen Avoid contact with the eyes, lips, and mouth Avoid contact with hair and dyed fabrics, which may be bleached by this product Skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Irritation may be erduced by using the product less frequently or in a lower concentartion. If going outside, apply sunscreen after using this product. If sensitivity develops or irritation becomes severe, stop use and ask a doctor. Keep out of reach of children If swallowed get medical help or call a poison control center immediately Keep away from excessive heat or heat sources

Reported adverse events (FAERS/openFDA)#

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