FDA.reportPublic FDA data

MDacne Customized Acne Treatment Cream Benzoyl Peroxide 5.0%

Manufacturer
MDAlgorithms Inc
Effective date
2024-09-26
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:22:26

Label at a glance#

ProductMDacne Customized Acne Treatment Benzoyl Peroxide
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Dosage and administration

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, appl...

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Indications:

INDICATIONS & USAGE SECTION

  • For the treatment of acne.
  • Clears up acne pimples and blemishes, and allows skin to heal. Helps prevent new pimples and blemishes from forming.

Warnings:

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • skin irritation and dryness is more likely to occur if you use another topical medication at the same time. If irritation occurs, use only one topical acne medication at a time.
  • avoid unnecessary sun expodure and use a sunscreen.
  • avoid contact with 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.

Do not use if you

OTC - DO NOT USE SECTION

  • have very sensitive skin. 
  • are sensitive to benzoyl peroxide. 

Stop using and ask a doctor

OTC - STOP USE SECTION

is irritation becomes severe.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

If pregnant or breastfeeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Directions:

DOSAGE & ADMINISTRATION 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, 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 sun sunscreen after using this product. If irritation or sensitivity develops, stop use of both products and ask a doctor.

Other information:

SPL UNCLASSIFIED SECTION

Store in a cool, dry place below 20ºC (70ºF).

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Ascorbic Acid (Vitamin C), C12-15 Alkyl Benzoate, Camellia Sinensis (Green Tea) Extract, Caprylyl Glycol, Cetearyl Alcohol, Cucumis Sativus (Cucumber) Fruit Extract, Cyclopentasiloxane, Cyclotetrasiloxane, Dimethicone, Glycerin, Glycyrrhiza Glabra (Licorice) Root Extract, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Lavandula Angustifolia (Lavender) Oil, Magnesium Aluminum Silicate, PEG 150 Distearate, Phenoxyethanol, Polysorbate 80, Potassium Sorbate, Propylene Glycol, Steareth-2, Steareth 20, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Com) Propanediol.

Questions:

OTC - QUESTIONS SECTION

Contact us at support@mdacne.com

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Label0.jpgOuter Label0.jpgInner Label.jpgInner Label.jpg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308693benzoyl peroxide 5 % Topical CreamPSN1
308693benzoyl peroxide 50 MG/ML Topical CreamSCD1
308693benzoyl peroxide 5 % Topical CreamSY1

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
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
ad75fcfd-a339-42a1-9c60-43ba2c654cfaProduct name120170810

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71804-536-00MDacne Customized Acne Treatment Benzoyl Peroxide15 mL in 1 TUBECREAM151
71804-536-00MDacne Customized Acne Treatment Benzoyl Peroxide1 in 1 BOXCREAM11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71804-536MDACNE CUSTOMIZED ACNE TREATMENT BENZOYL PEROXIDE (BENZOYL PEROXIDE) CREAM [MDALGORITHMS INC]1Current NDC, 2 package rows20241004_236e8d2e-ccd4-0a15-e063-6394a90a73e9.zip

Products#

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

DailyMed product names page 1 of 1 · 26 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71804-53671804-536-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CUCUMBERYY7C30VXJTIACT
CYCLOMETHICONE 50THT5PCI0RIACT
CYCLOMETHICONE 4CZ227117JEIACT
DIMETHICONE92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
LAVENDER OILZBP1YXW0H8IACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARETH-2V56DFE46J5IACT
STEARETH-20L0Q8IK9E08IACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
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
MDacne Customized Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEMDAlgorithms Inc236e8d2e-ccd4-0a15-e063-6394a90a73e92024-09-26WarningsExact identifier
ndc (package): 71804-536-00
ndc (product): 71804-536
ndc11 (package): 71804053600
spl id: 236eac1b-aa16-1217-e063-6394a90a08bf
spl set id: 236e8d2e-ccd4-0a15-e063-6394a90a73e9

Reported adverse events (FAERS/openFDA)#

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