MDacne Customized Cream (Benzoyl Peroxide)

Manufacturer
MDalgorithms Inc.
Effective date
2022-02-09
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:48:09

Label at a glance#

ProductMDacne Customized Cream (Benzoyl Peroxide)
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Label contents#

Full prescribing information#

DRUG FACTS:

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient:

Benzoyl Peroxide 5.0%

OTC - PURPOSE SECTION

Purpose

Acne Treatment

INDICATIONS & USAGE SECTION

Indications: ■ 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 SECTION

Warnings For external use only. When using this
product ■ 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 one time. ■ avoid unnecessary sun
exposure 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 ■ have
very sensitive skin. ■ are sensitive to benzoyl
peroxide. Stop use and ask a doctor if ■ irritation
becomes severe.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of the reach of children. If swallowed,
get medical help or contact a Poison Control Center right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast feeding, ask

a health professional before use.

DOSAGE & ADMINISTRATION SECTION

Directions: ■ 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 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.

INACTIVE INGREDIENT SECTION

Other Ingredients: 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, Tocopherol
Acetate (Vitamin E), Zemea (Corn) Propanediol.

OTC - QUESTIONS SECTION

Questions? Dist. by Mdalgorithms Inc. San Francisco,

CA 94104. Manufactured in the USA. For customer

support contact us at  support@mdacne.com

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MDacne

Customized

Treatment

Cream

Night

Dermatologist Tested

Benzoyl Peroxide 5.0%

0.5 Oz. | 15 mL

71804-250 .5OZ71804-250 .5OZ

res

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

FDA-Initiated Inactive NDC Indexing#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71804-250-07MDacne Customized Cream (Benzoyl Peroxide)15 mL in 1 TUBECREAM152

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71804-250MDACNE CUSTOMIZED CREAM (BENZOYL PEROXIDE) (BENZOYL PEROXIDE 5%) CREAM [MDALGORITHMS INC.]2Legacy NDC, 1 package rows20220210_9727b5eb-79f4-4275-96ac-3b81f4cc973e.zip

Products#

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

DailyMed product names page 1 of 1 · 29 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71804-25071804-250-07

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

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
d5846fe1-a82e-437e-babe-429f6a9abc649727b5eb-79f4-4275-96ac-3b81f4cc973e2022-02-09WarningsExact identifier
spl id: d5846fe1-a82e-437e-babe-429f6a9abc64
spl set id: 9727b5eb-79f4-4275-96ac-3b81f4cc973e

Reported adverse events (FAERS/openFDA)#

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