warnings
WARNINGS External Use Only. Not for ophthalmic Use. Avoid prolonged sun exposure, tanning booths, and sunlamps.
FDA label 6a90ff7b-d146-4932-9520-e63f1b75ee26
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
- SPL set ID
- a817fc08-117d-4199-8792-3871aac56a26
- SPL ID
- 6a90ff7b-d146-4932-9520-e63f1b75ee26
- Version
- 1
- Effective date
- 2010-12-27
- Source export date
- 2026-09-28
- Source partition
- 13
- Source file
- https://download.open.fda.gov/drug/label/drug-label-0013-of-0014.json.zip
- Source object key
- raw/openfda/drug-label/2026-09-28/e78bf8aa9f90ab13e640d254dfbd4fe5bfeca4995ec5f9d51bce3356e249cab7/drug-label-0013-of-0014.json.zip
- Source manifest SHA-256
- cd2e66336a5cd2223fa3995098fdbdb84c6a7ee5c0a4addb236ccb22dd1e6887
- Import run
- 20260929T050834Z
- Imported at
- 2026-09-29 06:31:21
Harmonized identifier links#
Every typed identifier imported from the complete openFDA harmonization object is paginated here; values are not reduced to a first match.
| Type | Scope | Identifier | Source field |
|---|---|---|---|
| spl id | 6a90ff7b-d146-4932-9520-e63f1b75ee26 | id | |
| spl set id | a817fc08-117d-4199-8792-3871aac56a26 | set_id |
Warnings cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
Adverse reactions cross-check#
openFDA text is shown for search and cross-checking; DailyMed SPL is canonical.
adverse reactions
Adverse Reactions Contact sensitization reactions are associated with the use of topical benzoyl peroxide and sulfur products, and may be expected to occur in 10 to 25 out of 1,000 patients. The most frequent adverse reaction associated with benzoyl peroxide and sulfur use are excessive erythema (redness) and peeling which may be expected to occur in 5 out of every 100 patients. Excessive erythema (redness) and peeling most frequently appear during the initial phase of medication use and may normally be controlled by reducing frequency of use.
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.