FDA.reportPublic FDA data

FDA label 80a4c051-479c-461a-8c7f-c5ddbfe99ee9

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
9dfc4f2d-3945-40a8-b260-f11eb1b2c742
SPL ID
80a4c051-479c-461a-8c7f-c5ddbfe99ee9
Version
4
Effective date
2018-06-12
Source export date
2026-10-12
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/2026-10-12/b939c18fdf51df171cf60ce5558819d08ac66bb16bb9991d48cbec91028d783e/drug-label-0004-of-0014.json.zip
Source manifest SHA-256
7e6b178df8f32cac9a78e0f5d09c588344509b04fe41effb1dde9102e2a45be6
Import run
20261013T011858Z
Imported at
2026-10-13 01:36:20

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 and cautions

WARNINGS: When using this product, avoid unnecessary sun exposure and use a sunscreen. PRECAUTIONS: General: For external use only. If severe irritation develops, discontinue use and institute appropriate therapy. After reaction clears, treatment may often be resumed with less frequent application. These preparations should not be used in or near the eyes or on mucous membranes.

Adverse reactions cross-check#

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Adverse reactions sections page 1 of 1 · 1 matching rows.

adverse reactions

ADVERSE REACTIONS: Allergic contact dermatitis and dryness have been reported with topical Benzoyl Peroxide therapy.

Reported adverse events (FAERS/openFDA)#

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