FDA.reportPublic FDA data

Benzoyl Peroxide

Manufacturer
Enrich Enterprises Xiamen Limited
Effective date
2024-05-20
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:47

Label at a glance#

ProductBenzoyl Peroxide
Active ingredientBENZOYL PEROXIDE
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 2.5%

OTC - PURPOSE SECTION

Acne Treatment

INDICATIONS & USAGE SECTION

Use For the treatment of acne.

WARNINGS SECTION

- For external use only.

OTC - DO NOT USE SECTION

Do not use if you

- Are sensitive to benzoyl peroxide.

OTC - WHEN USING SECTION

When using this product

- Avoid unnecessary sun exposure and use an SPF.

-Avoid contact with the eyes, lips, mouth and hair.

- Skin irritation, redness, burning, itching or peeling may occur.

- Only use one topical acne medication at a time as skin irritation and dryness is more likely to occur.

- Keep out of reach of children.

-If swallowed get medical help or call poison control center immediately.

OTC - STOP USE SECTION

- If swallowed get medical help or call poison control center immediately.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

- Keep out of reach of children.

DOSAGE & ADMINISTRATION SECTION

- Clean the skin gently before applying this product.

- Cover the affected area with a fingertip unit of product once or twice daily.

- If bothersome dryness or peeling occurs, reduce application to once a day or every other day.

INACTIVE INGREDIENT SECTION

Other Ingredients: Water, Propanediol, Glycerin, Carbomer, Sodium Phytate, Sodium Hydroxide

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

84339-001-0184339-001-01

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
a46239a7-5963-4008-8cbb-6b9000f497ebProduct name120250721
b382b4e1-6b48-45f6-bffc-e61b00b0ce19Product name320250317
d9d61457-6a5a-41fc-b418-e5479a2904b7Product name220230303
32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
13e7e7e3-e885-4c79-af6d-dad1aedbb06eProduct name120220128
4a7d44fe-774d-404b-aad0-8a90fe78375aProduct name420211025
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
84339-001-012025-07-29C16284748780-13b156c62-2742-fb37-e063-e6dba90a4e0784339-001

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
84339-001-01Benzoyl Peroxide1 in 1 BOXGEL11
84339-001-01Benzoyl Peroxide50 mL in 1 TUBEGEL501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
84339-001BENZOYL PEROXIDE GEL [ENRICH ENTERPRISES XIAMEN LIMITED]12 package rows20240522_18dddb5e-d3e0-2e8b-e063-6394a90ae28f.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
84339-00184339-001-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9804Q93RCW27EIACT
SODIUM HYDROXIDE55X04QC32IIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB
PROPANEDIOL5965N8W85TIACT
PHYTATE SODIUM88496G1ERLIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
18dddb5e-d3e1-2e8b-e063-6394a90ae28f18dddb5e-d3e0-2e8b-e063-6394a90ae28f2024-05-20WarningsExact identifier
spl id: 18dddb5e-d3e1-2e8b-e063-6394a90ae28f
spl set id: 18dddb5e-d3e0-2e8b-e063-6394a90ae28f

Reported adverse events (FAERS/openFDA)#

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