5 Percent Benzoyl Peroxide Cleanser

Manufacturer
Brand Evangelists for Beauty Limited | Orean Personal Care Ltd.
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:59:58

Label at a glance#

Product5 Percent Benzoyl Peroxide Cleanser
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Indications and uses

• for the treatment of acne.

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.• wet area to be cleansed • apply acne wash and gently massage area for 1-2 minutes • rinse thoroughly and pat dry • because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 times da...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5%

Purpose

OTC - PURPOSE SECTION

Acne Medication

Uses

INDICATIONS & USAGE SECTION

• for the treatment of acne.

Warnings

WARNINGS SECTION

For external use only.

Do not use if

OTC - DO NOT USE SECTION

• you have very sensitive skin• 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.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation becomes severe.

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

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.• wet area to be cleansed • apply acne wash and gently massage area for 1-2 minutes • rinse thoroughly and pat dry • because excessive drying of the skin may occur, start with one application daily, then gradually increase to 2 or 3 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 a broad spectrum sunscreen after using this product • if irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Water), Glycerin, Sodium Laurylglucosides Hydroxypropylsulfonate, Decyl Glucoside, Stearic Acid, Phenoxyethanol, Acrylates/C10-30 Alkyl Acrylate Crosspolymer, Polyacrylate Crosspolymer-6, Sodium Chloride, Ethylhexylglycerin, SodiumHydroxide, Polyquaternium-10, Trisodium Ethylenediamine Disuccinate, Hydrolyzed Sodium Hyaluronate, Sodium Hyaluronate, t-Butyl Alcohol.

Questions or Comments?

OTC - QUESTIONS SECTION

Call toll free (833) 981-2335

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

inner cartoninner cartonouter cartonouter cartontube labeltube label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308696benzoyl peroxide 5 % Medicated Liquid SoapPSN2
308696benzoyl peroxide 50 MG/ML Medicated Liquid SoapSCD2
308696benzoyl peroxide 5 % Medicated Liquid SoapSY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
81136-023-015 Percent Benzoyl Peroxide Cleanser150 mL in 1 TUBEGEL1502
81136-023-015 Percent Benzoyl Peroxide Cleanser1 in 1 CARTONGEL12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
81136-0235 PERCENT BENZOYL PEROXIDE CLEANSER (BENZOYL PEROXIDE) GEL [BRAND EVANGELISTS FOR BEAUTY LIMITED]2Current NDC, Legacy NDC, 2 package rows20231111_e82469e2-606a-4263-9aaa-08596b59ff6b.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81136-02381136-023-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 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
5 Percent Benzoyl Peroxide CleanserBENZOYL PEROXIDEBrand Evangelists for Beauty Limitede82469e2-606a-4263-9aaa-08596b59ff6b2023-11-10WarningsExact identifier
ndc (package): 81136-023-01
ndc (product): 81136-023
ndc11 (package): 81136002301
spl id: 09c77795-2e82-22c2-e063-6294a90afc96
spl set id: e82469e2-606a-4263-9aaa-08596b59ff6b

Reported adverse events (FAERS/openFDA)#

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