ACNE WIPEOUT ALL DAY BREAKOUT CONTROL

Manufacturer
University Medical Pharmaceuticals Corp.
Effective date
2020-10-02
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:38:05

Label at a glance#

ProductACNE WIPEOUT ALL DAY BREAKOUT CONTROL
Active ingredientBENZOYL PEROXIDE
Label structure10 sections

Dosage and administration

Adults and children 12 years of age and older: Use every morning after cleansing with Acne Wipeout™ Clear Pore Oil-Free Cleanser. Apply a dime-size amount to clean skin, avoiding the eye area. Do not rinse. If bothersome dryness or irritation occurs, reduce frequency of use. May be applied all over face to help control future breakouts.

Storage and handling

store at room temperature (68° to 77° F) Protect from freezing

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5% w/v

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

• For the treatment of acne

Warnings

WARNINGS SECTION

For external use only.

Do not use • If you are sensitive to Benzoyl Peroxide or have very sensitive skin. This product may cause irritation. Ask a doctor or pharmacist before use • If you are using other topical acne drugs at the same time or right after use of this product. This may increase dryness, redness or irritation of the skin. If this occurs, only one medication should be used unless a doctor directs otherwise.
When using this product • Avoid contact with eyes. If contact occurs, flush thoroughly with water. Keep away from lips and mouth. • Avoid unnecessary sun exposure and use a sunscreen. • Avoid product contact with hair and dyed fabrics, including towels, carpets and clothing which may be bleached by this product.

Stop use and ask a doctor if
• excessive irritation occurs.

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 immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and older:
Use every morning after cleansing with Acne Wipeout™ Clear Pore Oil-Free Cleanser. Apply a dime-size amount to clean skin, avoiding the eye area. Do not rinse. If bothersome dryness or irritation occurs, reduce frequency of use. May be applied all over face to help control future breakouts.

Other information

STORAGE AND HANDLING SECTION

  • store at room temperature (68° to 77° F)
  • Protect from freezing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water (Aqua), Sodium C14-16 Olefin Sulfonate, PEG-8, Disodium Laureth Sulfosuccinate, Polyacrylate-1 Crosspolymer, Cocamidopropyl Betaine, Allyl Methacrylates Crosspolymer, Butylene Glycol, Glycerin, DMDM Hydantoin, Tocopheryl Acetate (Vitamin E Acetate), Glycyrrhiza Glabra (Licorice) Root Extract, Calendula Officinalis Flower Extract, Hamamelis Virginiana (Witch Hazel) Extract, Citric Acid, Tetrasodium EDTA, Sodium Hydroxide, Fragrance, Sodium Benzotriazolyl Butylphenol Sulfonate, Benzoic Acid.

OTC - QUESTIONS SECTION

Questions? call toll free 855-299-8800

SPL UNCLASSIFIED SECTION

DERMATOLOGICAL FIRST LINE ACNE CARE

HYDRATING CREAM

TIME-RELEASED

5% BENZOYL PEROXIDE ACNE TREATMENT

MINIMIZES IRRITATION AND DRYNESS

PART OF THE ACNE WIPEOUT CLINICAL ACNE SYSTEM

acnewipeout.com

made in usa

UNIVERSITY MEDICAL

PHARMACEUTICALS CORP

9671 Irvine Center Drive

Irvine, CA 92618 ©2020


EFFECTIVE CLEARING + HYDRATION ALL DAY LONG

NON-COMEDOGENIC

FRAGRANCE FREE

PARABEN FREE

All Day Breakout Control delivers micronized, time-released benzoyl peroxide into pores to kill acne bacteria all day long—while hydrating skin and minimizing irritation and dryness.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrate1Hydrate1

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
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32012d5c-25ac-49c7-9d4c-1313177fff7cProduct name120230112
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3f45980c-c196-47e5-0e5e-48b7c57327c5Product name520200428
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252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50544-152-002023-01-30C16284748780-1f386c649-d4f4-0266-e053-dadaa90a7c1aACNE WIPEOUT™ ALL DAY BREAKOUT CONTROL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50544-152-00ACNE WIPEOUT ALL DAY BREAKOUT CONTROL1 in 1 CARTONCREAM11
50544-152-00ACNE WIPEOUT ALL DAY BREAKOUT CONTROL60 mL in 1 TUBECREAM601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50544-152ACNE WIPEOUT ALL DAY BREAKOUT CONTROL (BENZOYL PEROXIDE) CREAM [UNIVERSITY MEDICAL PHARMACEUTICALS CORP.]1Legacy NDC, 2 package rows20210213_2b004dfa-2c72-40ec-9b06-60502b3b6ce9.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50544-15250544-152-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 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
13c12c8d-c652-4690-875f-aa63b4c94d0c2b004dfa-2c72-40ec-9b06-60502b3b6ce92020-10-02WarningsExact identifier
spl id: 13c12c8d-c652-4690-875f-aa63b4c94d0c
spl set id: 2b004dfa-2c72-40ec-9b06-60502b3b6ce9

Reported adverse events (FAERS/openFDA)#

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