FDA label b8e5bf77-248f-4265-8c96-242a0b415a9a

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
21f8c814-2eb8-4028-9b5f-57a52c1e0859
SPL ID
b8e5bf77-248f-4265-8c96-242a0b415a9a
Version
2
Effective date
2019-01-09
Source export date
2026-10-12
Source partition
12
Source file
https://download.open.fda.gov/drug/label/drug-label-0012-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-10-12/edd23646015c9adc800cdbe2b778398a2d2b70e90dce5721ef2b191499a0397f/drug-label-0012-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 02:50:13

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: Avoid unnecessary sun exposure and use sunscreen (GMC MEDICAL SPF50+). Avoid contact with the eyes, lips and mouth. Avoid contact with hair and dyed fabrics, which may be bleached by this product. Using other topical acne drugs at the same time or right after use of this product may increase dryness or irritation of the skin. Only one drug should be used unless directed by a doctor. Skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently. Stop use and ask a doctor if: Irritation becomes severe Sensitivity develops or increases No substantial improvement occurs within 3 to 4 weeks or for more severe cases 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.