FDA.reportPublic FDA data

FDA label 170716cd-77d4-4e03-9efc-3905b391a88b

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
8287f7cf-17ff-44d4-ad23-9c85d2d69f90
SPL ID
170716cd-77d4-4e03-9efc-3905b391a88b
Version
3
Effective date
2019-09-24
Source export date
2026-09-28
Source partition
4
Source file
https://download.open.fda.gov/drug/label/drug-label-0004-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/c7ca0b7091cdaeab3f27713a6eef00adcf8fe722383633ddce61531b4c840544/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:22:46

Warnings cross-check#

openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.

Warnings sections page 1 of 1 · 4 matching rows.

warnings

Warnings For external use only When using this product avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water. 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. limit use to the face and neck Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

warnings

Caution For external use only. Avoid contact with eyes or mouth. If product gets into the eyes or in mouth rinse thoroughly with water. Stop use if skin irritation occurs. May not be suitable for very dry skin. Keep out of reach of children.

warnings

Warnings For external use only When using this product avoid contact with the eyes. If product gets into the eyes, rinse thoroughly with water. 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. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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 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 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. skin irritation may occur, characterized by redness, burning, itching, peeling or possibly swelling. Irritation may be reduced by using the product less frequently or in a lower concentration. Stop use and ask a doctor if 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.