Benzoyl Peroxide 10% Gel

Manufacturer
Axia Medical Solutions, LLC
Effective date
2019-11-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:01:36

Label at a glance#

ProductBenzoyl Peroxide 10% 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 10%

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

BP LabelBP Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
486131benzoyl peroxide 10 % Topical GelPSN2
486131benzoyl peroxide 0.1 MG/MG Topical GelSCD2
486131benzoyl peroxide 10 % Topical GelSY2

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
68723-306-022021-01-29C16284748780-1ba0f9c33-344d-a910-e053-dadaa90a0b85Dermesse Benzoyl Peroxide 10% Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68723-306-02Benzoyl Peroxide 10% Gel59.3 g in 1 BOTTLE, PLASTICGEL59.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68723-306BENZOYL PEROXIDE 10% GEL (BENZOYL PEROXIDE) GEL [AXIA MEDICAL SOLUTIONS, LLC]2Legacy NDC, 1 package rows20191122_8cb19ffe-f7c0-4500-a56d-234fd8871f87.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BENZOYL PEROXIDEACTIVE INGREDIENTW9WZN9A0GM1
BENZOYL PEROXIDEACTIVE MOIETYW9WZN9A0GM1
ALLANTOININACTIVE INGREDIENT344S277G0Z1
ALOE VERA LEAFINACTIVE INGREDIENTZY81Z83H0X1
BENZYL ALCOHOLINACTIVE INGREDIENTLKG8494WBH1
CARBOMER INTERPOLYMER TYPE A (55000 CPS)INACTIVE INGREDIENT59TL3WG5CO1
DISODIUM LAURETH SULFOSUCCINATEINACTIVE INGREDIENTD6DH1DTN7E1
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
HYALURONATE SODIUMINACTIVE INGREDIENTYSE9PPT4TH1
PANTHENOLINACTIVE INGREDIENTWV9CM0O67Z1
POLYETHYLENE GLYCOL 400INACTIVE INGREDIENTB697894SGQ1
PPG-14 PALMETH-60 HEXYL DICARBAMATEINACTIVE INGREDIENT376C96Y6AL1
TROLAMINEINACTIVE INGREDIENT9O3K93S3TK1
WATERINACTIVE INGREDIENT059QF0KO0R1

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
68723-30668723-306-02

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 5 · 268 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
TROLAMINETROLAMINE9O3K93S3TKSOAP / TOPICAL0.08 %w/wExact identifier — unii candidate
22 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCREAM, AUGMENTED / TOPICAL55 mgExact identifier — unii candidate
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BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHGEL / TOPICAL185 mgExact identifier — unii candidate
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HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THINJECTION, SUSPENSION / INTRA-ARTICULAR23 mgExact identifier — unii candidate
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GLYCERINGLYCERINPDC6A3C0OXINJECTION / INTRAMUSCULAR450 mgExact identifier — unii candidate
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POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAVENOUS28216 mgExact identifier — unii candidate
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EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, EMULSION / INTRAVENOUS59 mgExact identifier — unii candidate
77 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION / OPHTHALMIC6 %w/vExact identifier — unii candidate
75 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKCREAM / VAGINAL56 mgExact identifier — unii candidate
22 equally ranked IID candidates
TROLAMINETROLAMINE9O3K93S3TKGEL / TOPICAL6 mgExact identifier — unii candidate
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BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCAPSULE, EXTENDED RELEASE / ORAL1.23 mgExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET, COATED / ORAL1 mgExact identifier — unii candidate
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EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
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TROLAMINETROLAMINE9O3K93S3TKSOLUTION / NASALNAExact identifier — unii candidate
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EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION, EXTENDED RELEASE / ORAL40 mgExact identifier — unii candidate
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BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHTABLET, DELAYED RELEASE / ORAL2.31 mgExact identifier — unii candidate
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POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQGEL / TOPICAL6300 mgExact identifier — unii candidate
36 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KDROPS / NASAL0.1 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQLOTION / TOPICAL5 %w/wExact identifier — unii candidate
36 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / RECTAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVERNOUS18 mgExact identifier — unii candidate
50 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THLOTION / TOPICAL0.01 %w/wExact identifier — unii candidate
5 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, DELAYED RELEASE / ORAL35 mgExact identifier — unii candidate
36 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM / VAGINAL3 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSOLUTION / ORAL70200 mgExact identifier — unii candidate
36 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KAEROSOL, FOAM / TOPICAL0.05 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSUSPENSION / TOPICAL1 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXFILM, EXTENDED RELEASE / BUCCAL34 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSUSPENSION / OPHTHALMIC58 mgExact identifier — unii candidate
75 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHSHAMPOO / TOPICAL1.25 %w/wExact identifier — unii candidate
50 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
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POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION / INTRAMUSCULAR406 mgExact identifier — unii candidate
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POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQTABLET, FILM COATED, EXTENDED RELEASE / ORAL2 mgExact identifier — unii candidate
36 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / OPHTHALMIC0.06 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / OPHTHALMIC4 mgExact identifier — unii candidate
77 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQSUPPOSITORY / RECTAL0.25 mg/mgExact identifier — unii candidate
36 equally ranked IID candidates
HYALURONATE SODIUMHYALURONATE SODIUMYSE9PPT4THGEL / TOPICAL463 mgExact identifier — unii candidate
5 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXOINTMENT / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXTABLET / ORAL42 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOAP / TOPICAL0.76 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXJELLY / TOPICALNAExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSOLUTION/ DROPS / OPHTHALMIC12 mgExact identifier — unii candidate
75 equally ranked IID candidates
POLYETHYLENE GLYCOL 400POLYETHYLENE GLYCOL 400B697894SGQINJECTION, SOLUTION / INTRAVENOUS24186 mgExact identifier — unii candidate
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BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / TOPICAL160 mgExact identifier — unii candidate
50 equally ranked IID candidates
BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii candidate
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BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRACAVITARY8.4 mgExact identifier — unii candidate
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BENZYL ALCOHOLBENZYL ALCOHOLLKG8494WBHINJECTION, SOLUTION / INTRAMUSCULAR500 mgExact identifier — unii candidate
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GLYCERINGLYCERINPDC6A3C0OXSUSPENSION/ DROPS / OPHTHALMIC2.5 %w/vExact identifier — unii candidate
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22 equally ranked IID candidates
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75 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLOTION / TOPICAL22 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVENOUS10 %w/vExact identifier — unii candidate
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77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRAVASCULAR0.48 mgExact identifier — unii candidate
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EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRAMUSCULAR1 mgExact identifier — unii candidate
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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
1b1f484c-58ef-4b9b-8810-616bed4c113b8cb19ffe-f7c0-4500-a56d-234fd8871f872019-11-21WarningsExact identifier
spl id: 1b1f484c-58ef-4b9b-8810-616bed4c113b
spl set id: 8cb19ffe-f7c0-4500-a56d-234fd8871f87

Reported adverse events (FAERS/openFDA)#

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