FDA label b2c25a1d-e301-402d-b5b6-c2f4a353aa3e

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
5a3f8bbf-22be-427b-83a9-f5573232ed5f
SPL ID
b2c25a1d-e301-402d-b5b6-c2f4a353aa3e
Version
2
Effective date
2016-11-29
Source export date
2026-09-28
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/2026-09-28/4bbc9760f647649b787710953d978bd6419e899ba8b90f32c3d972aae43947f8/drug-label-0010-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 06:11:29

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 reduced by using this product less frequently or in a lower concentration. Stop use and ask a doctor if irritation becomes severe If pregnant or breast-feeding ask a health professional before use.

Reported adverse events (FAERS/openFDA)#

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