Benzoyl Peroxide 5% Gel

Manufacturer
Axia Medical Solutions, LLC
Effective date
2021-07-12
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:41:22

Label at a glance#

ProductBenzoyl Peroxide 5% Gel
Active ingredientBENZOYL PEROXIDE
Label structure13 sections

Indications and uses

For the treatment of acne.

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 to 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 outsi...

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Benzoyl Peroxide 5%

Purpose

OTC - PURPOSE SECTION

Acne Treatment

USES:

INDICATIONS & USAGE SECTION

For the treatment of acne.

WARNINGS:

WARNINGS SECTION

For external use only.

Do not use if you:

OTC - DO NOT USE SECTION

• Have sensitive skin. • Are sensitive to benzoyl peroxide.

When using the 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 this 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 become severe.

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

• 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 to 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 sunscreen after using this product.  If irritation or sensitivity develops, stop use of both products and ask a doctor.

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Allantoin, Aloe Barbadensis Leaf Extract, Benzyl Alcohol, Carbomer, Disodium EDTA, Disodium Laureth Sulfosuccinate, Glycerin, Panthenol, PEG-8, PEG-14 Palmeth-60 Hexyl Dicarbamate, Sodium Hyaluronate, Triethanolamine, and Water.

OTHER INFORMATION:

OTHER SAFETY INFORMATION

• Store at controlled room temperature 15-30°C (59-86°F)

Questions?:

OTC - QUESTIONS SECTION

866-494-4466, Mon-Fri 8:00AM-5:00PM

Dist. By Axia Medical Solutions, 2105 Camino Vida Roble, Carlsbad, Ca. 92011

www.dermesse.com     866-494-4466 office, 760-931-8267 fax

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Benzoyl Peroxide 5 GelBenzoyl Peroxide 5 GelBenzoyl Peroxide 5 GelBenzoyl Peroxide 5 Gel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308694benzoyl peroxide 5 % Topical GelPSN4
308694benzoyl peroxide 0.05 MG/MG Topical GelSCD4
308694benzoyl peroxide 5 % Topical GelSY4

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68723-305-022023-01-30C16284748780-1f386c649-e27e-0266-e053-dadaa90a7c1aDermesse Benzoyl Peroxide 5% Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68723-305-02Benzoyl Peroxide 5% Gel57 mg in 1 BOTTLE, PLASTICGEL574

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68723-305BENZOYL PEROXIDE 5% GEL (BENZOYL PEROXIDE) GEL [AXIA MEDICAL SOLUTIONS, LLC]4Legacy NDC, 1 package rows20210713_a0e4581a-ea6b-4c82-998f-4ea4103c857b.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68723-30568723-305-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 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
e5a2beb3-04a4-47e4-87a2-e66f6ee04407a0e4581a-ea6b-4c82-998f-4ea4103c857b2021-07-12WarningsExact identifier
spl id: e5a2beb3-04a4-47e4-87a2-e66f6ee04407
spl set id: a0e4581a-ea6b-4c82-998f-4ea4103c857b

Reported adverse events (FAERS/openFDA)#

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