FDA.reportPublic FDA data

MEDPURA Benzoyl Peroxide

Manufacturer
Akron Pharma Inc.
Effective date
2026-01-13
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:32:25

Label at a glance#

ProductMEDPURA Benzoyl Peroxide
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Dosage and administration

Shake well 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. wet area to be cleansed apply acne wash and gently massage area for 1-2 minutes rinse thoroughly and pat dry because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or thr...

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 5% 

Benzoyl peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

for the treatment of acne

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use this medication if you have very sensitive skin or if you 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, eyelids and mucous membranes.
  • 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • Shake well
  • 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.
  • wet area to be cleansed
  • apply acne wash and gently massage area for 1-2 minutes
  • 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. 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

Benzoyl peroxide, Carbomer, Citric acid monohydrate, Edetate Disodium, Glycerin,Imidurea, Sodium alpha olefin sulfonate,

Sodium hydroxide, Purified water.

Questions or comments?

OTC - QUESTIONS SECTION

call toll-free 1-877-225-6999

SPL UNCLASSIFIED SECTION

Manufactured for:

Akron Pharma, Inc.
Fairfield, NJ-07004
www.akronpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11223344

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
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
71399-9234-52023-03-26C16284748780-1f386c64a-09e8-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Acne Treatment Wash
71399-9234-82023-03-26C16284748780-1f386c64a-09e8-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Acne Treatment Wash
71399-9236-52023-03-26C16284748780-1f386c64a-09e8-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Acne Treatment Wash
71399-9236-82023-03-26C16284748780-1f386c64a-09e8-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Acne Treatment Wash
71399-9234-52023-01-30C16284748780-1f386c64a-09e8-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Acne Treatment Wash
71399-9234-82023-01-30C16284748780-1f386c64a-09e8-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Acne Treatment Wash
71399-9236-52023-01-30C16284748780-1f386c64a-09e8-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Acne Treatment Wash
71399-9236-82023-01-30C16284748780-1f386c64a-09e8-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Acne Treatment Wash

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-9234-5MEDPURA Benzoyl Peroxide148 mL in 1 BOTTLELIQUID1484
71399-9234-8MEDPURA Benzoyl Peroxide237 mL in 1 BOTTLELIQUID2374
71399-9236-5MEDPURA Benzoyl Peroxide148 mL in 1 BOTTLELIQUID1484
71399-9236-8MEDPURA Benzoyl Peroxide237 mL in 1 BOTTLELIQUID2374

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-9234-5GM - Gram71399-9234df744d6d-319b-46ad-b3a9-c346997d6d4412021-12-08
71399-9234-8GM - Gram71399-9234e565aaaf-8150-49ab-a5fd-c211d0321f6e12021-12-08
71399-9236-5GM - Gram71399-923606d46abd-5a0f-4bb3-a37d-eabf5262dfe112021-12-08
71399-9236-8GM - Gram71399-923665d66e5f-333f-42d5-8afe-7b29bbf7e81212021-12-08

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-923471399-9234-5, 71399-9234-8
71399-923671399-9236-5, 71399-9236-8

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER 9804Q93RCW27EIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
IMIDUREAM629807ATLIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
CARBOMER 9804Q93RCW27EIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
IMIDUREAM629807ATLIACT
SODIUM C14-16 OLEFIN SULFONATEO9W3D3YF5UIACT
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
MEDPURA Benzoyl PeroxideBENZOYL PEROXIDEAkron Pharma Inc.1b051efe-054b-42a0-915a-b87885bd3c542026-01-13WarningsExact identifier
ndc (package): 71399-9236-8
ndc (package): 71399-9234-8
ndc (package): 71399-9236-5
ndc (package): 71399-9234-5
ndc (product): 71399-9234
ndc (product): 71399-9236
ndc11 (package): 71399923405
ndc11 (package): 71399923608
ndc11 (package): 71399923408
ndc11 (package): 71399923605
spl id: 4849d778-5066-277d-e063-6294a90a798a
spl set id: 1b051efe-054b-42a0-915a-b87885bd3c54

Reported adverse events (FAERS/openFDA)#

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