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FDA label 66254950-81e1-3ded-e053-2991aa0ae252

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
d2777f5a-458c-49a0-8907-a95c4b23fd9d
SPL ID
66254950-81e1-3ded-e053-2991aa0ae252
Version
3
Effective date
2018-02-26
Source export date
2026-09-28
Source partition
1
Source file
https://download.open.fda.gov/drug/label/drug-label-0001-of-0014.json.zip
Source object key
raw/openfda/drug-label/2026-09-28/9c7783846d422acb0c9e59457606951c785a7d28cc631c8cc4839d0dc7c55f39/drug-label-0001-of-0014.json.zip
Source manifest SHA-256
cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
Import run
20260929T050834Z
Imported at
2026-09-29 05:13:05

Adverse reactions cross-check#

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

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

adverse reactions

ADVERSE REACTIONS Adverse reactions which may be encountered with topical benzoyl peroxide include excessive drying (manifested by marked peeling, erythema and possible edema), and allergic contact sensitization. Excessive dryness would appear to occur in approximately 2 patients in 50. Pertinent literature would seem to indicate that allergic sensitization to benzoyl peroxide may occur in 10 to 25 patients in 1,000. 7,8,9 There is one reference that reports an occurrence of sensitization in 5 of 100 patients. 10

Reported adverse events (FAERS/openFDA)#

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