FDA.reportPublic FDA data

MEDPURA 5% and 10% Benzoyl Peroxide Aqueous Base, Acne Treatment Gel

Manufacturer
Akron Pharma Inc.
Effective date
2026-01-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:34:41

Label at a glance#

ProductMEDPURA Benzoyl Peroxide Aqueous Base, Acne Treatment Gel
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Dosage and administration

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. 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, start with one application daily, then gradually increase to t...

Storage and handling

store at 20°-25°C (68°-77°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

  • 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.
  • avoid unnecessary sun exposure and use a sunscreen
  • avoid contact with the eyes, lips, and mouth
  • avoid contact with hair and 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.

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

  • 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.
  • 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, 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 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carbomer, docusate sodium, methyl salicylate, purified water, propylene glycol, sodium hydroxide,

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

112233445566

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
486131benzoyl peroxide 10 % Topical GelPSN4
308694benzoyl peroxide 5 % Topical GelPSN4
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD4
486131benzoyl peroxide 0.1 MG/MG Topical GelSCD4
486131benzoyl peroxide 10 % Topical GelSY4
308694benzoyl peroxide 5 % Topical GelSY4

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130371399947499GTIN-13: 0371399947499
EAN-13: 0371399947499
GTIN-12: 371399947499
UPC-A: 371399947499
GTIN storage (14 digits): 00371399947499		Benzoyl prexide 10 gel 90g CARTON_12SEP2024JPG.jpg
BarcodeEAN-130371399947857GTIN-13: 0371399947857
EAN-13: 0371399947857
GTIN-12: 371399947857
UPC-A: 371399947857
GTIN storage (14 digits): 00371399947857		Benzoyl Prexide 5 gel 42.5g Box Cartton_12SEP2024 JPG.jpg
BarcodeEAN-130371399947895GTIN-13: 0371399947895
EAN-13: 0371399947895
GTIN-12: 371399947895
UPC-A: 371399947895
GTIN storage (14 digits): 00371399947895		Benzoyl prexide 5 gel 90g Cartton 12SEP2024_JPG.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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-9474-52023-04-03C16284748780-1f386c649-a974-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Aqueous Base, Acne Treatment Gel
71399-9474-62023-04-03C16284748780-1f386c649-a974-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Aqueous Base, Acne Treatment Gel
71399-9478-52023-04-03C16284748780-1f386c649-a974-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Aqueous Base, Acne Treatment Gel
71399-9478-62023-04-03C16284748780-1f386c649-a974-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Aqueous Base, Acne Treatment Gel
71399-9474-52023-01-30C16284748780-1f386c649-a974-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Aqueous Base, Acne Treatment Gel
71399-9474-62023-01-30C16284748780-1f386c649-a974-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Aqueous Base, Acne Treatment Gel
71399-9478-52023-01-30C16284748780-1f386c649-a974-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Aqueous Base, Acne Treatment Gel
71399-9478-62023-01-30C16284748780-1f386c649-a974-0266-e053-dadaa90a7c1aMEDPURA 5% and 10% Benzoyl Peroxide Aqueous Base, Acne Treatment Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-9474-5MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel42.5 mL in 1 TUBEGEL42.54
71399-9474-5MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel1 in 1 CARTONGEL14
71399-9474-6MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel1 in 1 CARTONGEL14
71399-9474-6MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel60 mL in 1 TUBEGEL604
71399-9474-9MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel1 in 1 CARTONGEL14
71399-9474-9MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel90 mL in 1 TUBEGEL904
71399-9478-5MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel42.5 mL in 1 TUBEGEL42.54
71399-9478-5MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel1 in 1 CARTONGEL14
71399-9478-6MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel1 in 1 CARTONGEL14
71399-9478-6MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel60 mL in 1 TUBEGEL604
71399-9478-9MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel90 mL in 1 TUBEGEL904
71399-9478-9MEDPURA Benzoyl PeroxideAqueous Base, Acne Treatment Gel1 in 1 CARTONGEL14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-9478-5GM - Gram71399-9478847e7c28-952a-4f14-8dc8-b76e293f4e8112021-12-08
71399-9478-6GM - Gram71399-9478bf61dca8-8b54-467d-9356-c90bee7529d312021-12-08
71399-9478-9GM - Gram71399-9478b098a1d7-a76c-4bdd-ac4f-a41bf340c9d812023-04-07
71399-9474-5GM - Gram71399-947430c4c84c-a5b6-4559-b7bd-afc6b92d7d4e12021-12-08
71399-9474-6GM - Gram71399-9474a9bf1e5c-236f-45df-9b4f-1703eb75751d12021-12-08
71399-9474-9GM - Gram71399-94748ea573da-5812-4cb1-8c33-ee8307aa47ed12023-04-07

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-947871399-9478-5, 71399-9478-6, 71399-9478-9
71399-947471399-9474-5, 71399-9474-6, 71399-9474-9

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0IACT
CARBOMER 9804Q93RCW27EIACT
METHYL SALICYLATELAV5U5022YIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB
DOCUSATE SODIUMF05Q2T2JA0IACT
CARBOMER 9804Q93RCW27EIACT
METHYL SALICYLATELAV5U5022YIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
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 Peroxide Aqueous Base, Acne Treatment GelBENZOYL PEROXIDEAkron Pharma Inc.b7d335d1-3022-4b28-913c-477152a7dad22026-01-23WarningsExact identifier
ndc (package): 71399-9474-9
ndc (package): 71399-9478-9
ndc (package): 71399-9474-5
ndc (package): 71399-9478-6
ndc (package): 71399-9478-5
ndc (package): 71399-9474-6
ndc (product): 71399-9478
ndc (product): 71399-9474
ndc11 (package): 71399947806
ndc11 (package): 71399947805
ndc11 (package): 71399947809
ndc11 (package): 71399947405
ndc11 (package): 71399947406
ndc11 (package): 71399947409
spl id: 4911da35-ce19-18af-e063-6394a90a5554
spl set id: b7d335d1-3022-4b28-913c-477152a7dad2

Reported adverse events (FAERS/openFDA)#

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