FDA.reportPublic FDA data

BENZOYL PEROXIDE 10% Topical wash

Manufacturer
Medcore LLC
Effective date
2025-10-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:39:46

Label at a glance#

ProductBENZOYL PEROXIDE 5% Topical wash
Active ingredientBENZOYL PEROXIDE
Label structure13 sections

Indications and uses

For the treatment of acne

Dosage and administration

adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day children under 2 years ask a doctor

Storage and handling

Store at room temperature 15°-30°C(59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

BENZOYL PEROXIDE 5% or 10%

Purpose

OTC - PURPOSE SECTION

Acne medication

Uses

INDICATIONS & USAGE SECTION

For the treatment of acne

Warnings

WARNINGS SECTION

For external use ONLY. Skin irritation and dryness is more likely to occur if you use another topical acne medication at the same time. Avoid unnessary sun exposure and use a sunscreen. Avoid contact with eyes, lips and mouth. Avoid contact with hair,dyed fabrics, which may be bleached by thisproduct. 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 lower concentration.If irritation or sensitivy develops stop use of both products and ask a doctor.

INSTRUCTIONS FOR USE

OTC - WHEN USING SECTION

Clean the skin thoroughly before applying this product. Cover the entire affected area with a thin layer one to three times daily. Because excessive drying of the skin may occur, 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

OTC - DO NOT USE SECTION

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of the 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

adults and children 2 years and olderapply externally to the affected area up to 3 to 4 times a day
children under 2 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

Store at room temperature 15°-30°C(59°-86°F) Avoid storing product in direct sunlight and protect product from excessive moisture.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED) cetyl alcohol edetate disodium glycerinGLYCERYL STEARATE/PEG-100 STEARATE laureth-12 magnesium aluminum silicate propylene glycol sodium lauroamphoacetate sodium coco-sulfate xanthan gum Water PHENOXYETHANOL

PRINCIPAL DISPLAY PANEL - 5% 5 OZ Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82461-312-05

Medcore LLC

BENZOYL PEROXIDE 5% Acne wash

5 OZ

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

Label-1Label-1

PRINCIPAL DISPLAY PANEL - 5% 8 OZ Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82461-312-08

Medcore LLC

BENZOYL PEROXIDE 5% Acne wash

8 OZ

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

Label-1Label-1

PRINCIPAL DISPLAY PANEL - 10% 5 OZ Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82461-313-05

Medcore LLC

BENZOYL PEROXIDE 10% Acne wash

5 OZ

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

Label-1Label-1

PRINCIPAL DISPLAY PANEL - 10% 8 OZ Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 82461-313-08

Medcore LLC

BENZOYL PEROXIDE 10% Acne wash

8 OZ

Manufactured For:
Medcore LLC
3048 Valley Rd.
Basking Ridge, NJ 07920
Questions or Comments Please call
908-280-2269

Label-1Label-1

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
142034benzoyl peroxide 10 % Medicated Liquid SoapPSN1
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN1
142034benzoyl peroxide 100 MG/ML Medicated Liquid SoapSCD1
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD1
142034benzoyl peroxide 10 % Medicated Liquid SoapSY1
308696benzoyl peroxide 5 % Medicated Liquid SoapSY1

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130382461313050GTIN-13: 0382461313050
EAN-13: 0382461313050
GTIN-12: 382461313050
UPC-A: 382461313050
GTIN storage (14 digits): 00382461313050		benzoyl-peroxide-03.jpg

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82461-312-05BENZOYL PEROXIDE 5% Topical wash148 mL in 1 BOTTLE, PUMPLIQUID1481
82461-312-08BENZOYL PEROXIDE 5% Topical wash236 mL in 1 BOTTLE, PUMPLIQUID2361
82461-313-05BENZOYL PEROXIDE 10% Topical wash148 mL in 1 BOTTLE, PUMPLIQUID1481
82461-313-08BENZOYL PEROXIDE 10% Topical wash236 mL in 1 BOTTLE, PUMPLIQUID2361

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
82461-312-05ML - Milliliter82461-312936edb7a-6e06-4235-97f3-8310a29d5a8912026-01-08
82461-312-08ML - Milliliter82461-31286e99049-5b74-460e-9e39-41dd17d4002412026-01-08
82461-313-05ML - Milliliter82461-31397430c75-6eaf-4bd0-b075-7809b938ba2512026-01-08
82461-313-08ML - Milliliter82461-313520750dd-59b0-46a7-9c0b-53a9bf562dc112026-01-08

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82461-31282461-312-05, 82461-312-08
82461-31382461-313-05, 82461-313-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 matching rows.

Name, UNII, Kind table
NameUNIIKind
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
SODIUM LAUROAMPHOACETATESLK428451LIACT
SODIUM COCO-SULFATE3599J29ANHIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
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
SODIUM LAUROAMPHOACETATESLK428451LIACT
SODIUM COCO-SULFATE3599J29ANHIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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 PEROXIDE 5% Topical washBENZOYL PEROXIDEMedcore LLC14bf3034-2fe8-44b9-9e26-e804b60468372025-10-22WarningsExact identifier
ndc (package): 82461-313-05
ndc (package): 82461-312-05
ndc (package): 82461-313-08
ndc (package): 82461-312-08
ndc (product): 82461-312
ndc (product): 82461-313
ndc11 (package): 82461031208
ndc11 (package): 82461031308
ndc11 (package): 82461031305
ndc11 (package): 82461031205
spl id: 14cd67f2-dc7d-484b-bd21-bcb09c7f779e
spl set id: 14bf3034-2fe8-44b9-9e26-e804b6046837

Reported adverse events (FAERS/openFDA)#

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