FDA.reportPublic FDA data

MDacne Body Acne Treatment Cream Benzoyl Peroxide 5%

Manufacturer
MDAlgorithms Inc
Effective date
2024-09-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:19:53

Label at a glance#

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

Dosage and administration

Cleanse the skin thoroughly before applying medication. Apply even layer over affected area. Do not use on broken skin or large parts of the body. *For best results apply one to three times per day.

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5.0%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

Use:

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.

  • Using other topical acne medications at the same time or immediately following use of this product may increase dryness or irritation of the skin.
    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 per day.

•  Do not use 

OTC - DO NOT USE SECTION

for prolonged periods without consulting a doctor.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, contact physician or Poison Control Center immediately.

Directions:

DOSAGE & ADMINISTRATION SECTION

Cleanse the skin thoroughly before applying medication. Apply even layer over affected area. Do not use on broken skin or large parts of the body. *For best results apply one to three times per day.

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) Extract, Dimethicone, Glycerin, Glycyrrhiza Glabra (Licorice) Extract, Hexylene Glycol, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Magnesium Aluminum Silicate, Melaleuca Alternifolia (Tea Tree) Oil, PEG-150 Stearate, Phenoxyethanol, Polysorbate-80, Potassium Sorbate, Propylene Glycol, Steareth-2, Steareth-20, Tetrasodium EDTA, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol.

Questions:

OTC - QUESTIONS SECTION

Contact us at support@mdacne.com

Package Labelling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label03.jpgLabel03.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
71804-532-00MDacne Body Acne Treatment Benzoyl Peroxide90 mL in 1 TUBECREAM901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71804-532MDACNE BODY ACNE TREATMENT BENZOYL PEROXIDE (BENZOYL PEROXIDE) CREAM [MDALGORITHMS INC]1Current NDC, 1 package rows20240921_97529268-c45c-49c0-8eb0-15c90def69ea.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71804-53271804-532-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 24 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
ALKYL (C12-15) BENZOATEA9EJ3J61HQIACT
GREEN TEA LEAFW2ZU1RY8B0IACT
CAPRYLYL GLYCOL00YIU5438UIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CUCUMBERYY7C30VXJTIACT
DIMETHICONE, UNSPECIFIED92RU3N3Y1OIACT
GLYCERINPDC6A3C0OXIACT
GLYCYRRHIZA GLABRA2788Z9758HIACT
HEXYLENE GLYCOLKEH0A3F75JIACT
MAGNESIUM ALUMINUM SILICATE6M3P64V0NCIACT
MELALEUCA ALTERNIFOLIA LEAFG43C57162KIACT
PEG-150 STEARATE7BSG7DF10QIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYSORBATE 806OZP39ZG8HIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARETH-2V56DFE46J5IACT
STEARETH-20L0Q8IK9E08IACT
EDETATE SODIUMMP1J8420LUIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
CORN0N8672707OIACT
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 Body Acne Treatment Benzoyl PeroxideBENZOYL PEROXIDEMDAlgorithms Inc97529268-c45c-49c0-8eb0-15c90def69ea2024-09-19WarningsExact identifier
ndc (package): 71804-532-00
ndc (product): 71804-532
ndc11 (package): 71804053200
spl id: 2275e071-2dca-99b9-e063-6394a90ad53f
spl set id: 97529268-c45c-49c0-8eb0-15c90def69ea

Reported adverse events (FAERS/openFDA)#

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