FDA label c048c2d1-4ebd-49dd-a8e4-0c374cd20c1e

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
934ec314-1ab7-45ee-a2fe-8bff3ff981b6
SPL ID
c048c2d1-4ebd-49dd-a8e4-0c374cd20c1e
Version
1
Effective date
2012-05-10
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 06:13:23

Warnings cross-check#

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

Warnings sections page 1 of 1 · 3 matching rows.

warnings

Warnings For external use only. When using this product 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 irritation becomes severe. 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. When using this product 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 irritation becomes severe. 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. Stop use and ask a doctor if irritation becomes severe. 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 the product less frequently or in a lower concentration if pregnant or breast-feeding, ask a health care professional before use. Do not use if you have very sensitive skin are sensitive to benzoyl peroxide. 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.