FDA.reportPublic FDA data

Benzoyl Peroxide

Manufacturer
Burel Pharmaceuticals, LLC | Groupe PARIMA Inc.
Effective date
2024-04-24
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:15:59

Label at a glance#

ProductBenzoyl Peroxide
Active ingredientBenzoyl Peroxide
Label structure13 sections

Dosage and administration

SHAKE WELL. Clean the skin thoroughly before applying this product. Sensitivity Test for a New User.  Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs,follow the directions stated below. One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 sec...

Storage and handling

Store at controlled room temperature, 15° - 30°C (59° - 86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

benzoyl peroxide USP, 5% or 10%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

INDICATIONS & USAGE SECTION

  • For the treatment of acne

Warnings:

WARNINGS SECTION

For external use only.

  • Avoid contact with eyes, eyelids, lips and mucous membranes.

Do not use if you

OTC - DO NOT USE SECTION

  • have very sensitive skin
  • are sensitive to benzoyl peroxide

When using this product

OTC - WHEN USING SECTION

  • Avoid unnecessary sun exposure and use a sunscreen.
  • Avoid contact with eyes, lips, and mouth.
  • Avoid contact with hair or 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.
  • 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.
  • Stop use and ask a doctor if irritation becomes severe.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

SHAKE WELL.

  • Clean the skin thoroughly before applying this product.
  • Sensitivity Test for a New User. Apply product sparingly to one or two small affected areas during the first 3 days. If no discomfort occurs,follow the directions stated below.
  • One to three times daily, wet skin and cover the entire affected area with a thin layer, liberally applying to areas to be cleansed. Massage gently into skin for 10-20 seconds working into a full lather, rinse thoroughly and pat dry.
  • Because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor.
  • If bothersome dryness or peeling occurs, reduce application to once a day or every other day.
  • If going outside, apply sunscreen after using this product.
  • Follow directions in the sunscreen labeling.
  • If irritation or sensitivity develops stop use of both products and ask a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature, 15° - 30°C (59° - 86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Carbomer interpolymer type A NF, cetyl alcohol NF, edetate disodium USP, glycerin USP, glyceryl stearate/PEG-100 stearate, laureth-12, magnesium aluminum silicate NF, propylene glycol USP, purified water USP, sodium coco-sulfate, sodium lauroamphoacetate, and xanthan gum NF.

SPL UNCLASSIFIED SECTION

Questions? Call 1-866-525-0688

Manufactured for:
Burel Pharmaceuticals, LLC
Mason, OH 45040 USA

Rev. 04/24

PRINCIPAL DISPLAY PANEL - 5% 5oz (148 g) Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 35573-453-91

BENZOYL
PEROXIDE
TOPICAL
WASH 5%

FOR TOPICAL USE ONLY

Net Weight 5 oz
(148 g)

burelpharma

 

lelyslelys

PRINCIPAL DISPLAY PANEL - 5% 8oz (237 g) Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 35573-453-08

BENZOYL
PEROXIDE
TOPICAL
WASH 5%

FOR TOPICAL USE ONLY

Net Weight 8 oz
(237 g)

burelpharma

lelyslelys

PRINCIPAL DISPLAY PANEL - 10% 5oz (148 g) Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 35573-454-91

BENZOYL
PEROXIDE
TOPICAL
WASH 10%

FOR TOPICAL USE ONLY

Net Weight 5 oz
(148 g)

burelpharma

lelys1
lelys1

PRINICIPAL DISPLAY PANEL - 10% 8oz (237 g) Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 35573-454-08

BENZOYL
PEROXIDE
TOPICAL
WASH 10%

FOR TOPICAL USE ONLY

Net Weight 8 oz
(237 g)

burelpharma

 
lelys3
lelys3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN4
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN4
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD4
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD4
142034benzoyl peroxide 10 % Medicated Liquid SoapSY4
308696benzoyl peroxide 5 % Medicated Liquid SoapSY4

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
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
d12e2d7c-bd6b-45d4-94f9-6df8e1b8b27bProduct name320200203
ee5c6de5-d9cd-454f-b250-7b19e5cf2992Product name420190619
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35573-453-08Benzoyl Peroxide237 mL in 1 BOTTLELIQUID2374
35573-453-91Benzoyl Peroxide148 mL in 1 BOTTLELIQUID1484
35573-454-08Benzoyl Peroxide237 mL in 1 BOTTLELIQUID2374
35573-454-91Benzoyl Peroxide148 mL in 1 BOTTLELIQUID1484

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
35573-453BENZOYL PEROXIDE LIQUID [BUREL PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240726_0617d42d-511d-4c1a-a919-b37abbc14efc.zip
35573-454BENZOYL PEROXIDE LIQUID [BUREL PHARMACEUTICALS, LLC]4Current NDC, Legacy NDC, 2 package rows20240726_0617d42d-511d-4c1a-a919-b37abbc14efc.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
35573-453-08GM - Gram35573-453d0e87e69-f9fd-4531-8f3e-3f66ba15c32c12022-05-04
35573-453-91GM - Gram35573-45394c86177-2ec0-430d-b536-aba227bfa74012022-05-04
35573-454-08GM - Gram35573-45431f84269-b555-4dd3-bf34-ac75b51ed34112022-05-04
35573-454-91GM - Gram35573-4542a38a15a-59ac-4c3c-ac29-99ce982db78f12022-05-04

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35573-45335573-453-91, 35573-453-08
35573-45435573-454-91, 35573-454-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

Name, UNII, Kind table
NameUNIIKind
Benzoyl PeroxideW9WZN9A0GMACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
cetyl alcohol936JST6JCNIACT
edetate disodium7FLD91C86KIACT
glycerinPDC6A3C0OXIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
laureth-12OAH19558U1IACT
magnesium aluminum silicate6M3P64V0NCIACT
propylene glycol6DC9Q167V3IACT
water059QF0KO0RIACT
sodium coco-sulfate3599J29ANHIACT
sodium lauroamphoacetateSLK428451LIACT
xanthan gumTTV12P4NEEIACT
Benzoyl PeroxideW9WZN9A0GMACTIB
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
cetyl alcohol936JST6JCNIACT
edetate disodium7FLD91C86KIACT
glycerinPDC6A3C0OXIACT
GLYCERYL STEARATE/PEG-100 STEARATERD25J5V947IACT
laureth-12OAH19558U1IACT
magnesium aluminum silicate6M3P64V0NCIACT
propylene glycol6DC9Q167V3IACT
water059QF0KO0RIACT
sodium coco-sulfate3599J29ANHIACT
sodium lauroamphoacetateSLK428451LIACT
xanthan gumTTV12P4NEEIACT

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
Benzoyl PeroxideBENZOYL PEROXIDEBurel Pharmaceuticals, LLC0617d42d-511d-4c1a-a919-b37abbc14efc2024-04-24WarningsExact identifier
ndc (package): 35573-454-91
ndc (package): 35573-453-91
ndc (package): 35573-454-08
ndc (package): 35573-453-08
ndc (product): 35573-453
ndc (product): 35573-454
ndc11 (package): 35573045391
ndc11 (package): 35573045308
ndc11 (package): 35573045408
ndc11 (package): 35573045491
spl id: d51a6f4b-982d-45aa-932f-a9527b294289
spl set id: 0617d42d-511d-4c1a-a919-b37abbc14efc

Reported adverse events (FAERS/openFDA)#

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