FDA label e4731a80-d4cc-44e6-b097-007da257488f

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
4a4c7181-9f28-4321-b07a-1bc6e3b5a130
SPL ID
e4731a80-d4cc-44e6-b097-007da257488f
Version
2
Effective date
2014-06-16
Source export date
2026-10-12
Source partition
10
Source file
https://download.open.fda.gov/drug/label/drug-label-0010-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/befa34274042a52f589b22fe2add0b1c6f0a385c96447c28303de164bb144af5/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:35:15

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 this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide When using this product – avoid unnecessary sun exposure and use a sunscreen – avoid contact with the eyes, lips and mouth – avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product – skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in lower concentrations. If irritation becomes severe, discontinue use. If irritation still continues, consult a doctor. Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor. Stop use and ask a doctor if skin irritation becomes severe. 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.