Benzoyl Peroxide

Manufacturer
Innovida Pharmaeutique Corporation
Effective date
2025-12-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
monthly-update
Hydrated at
2026-06-03 17:47:05

Label at a glance#

ProductBenzoyl Peroxide
Active ingredientBENZOYL PEROXIDE
Label structure8 sections

Indications and uses

For the treatment of acne

Dosage and administration

Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness or peeling occurs, reduce application to once a day.

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 this medication if you have very sensitive skin or if you are sensitive to benzoyl peroxide.
When using this productkeep away from eyes, lips and mouth
• avoid unnecessary sun exposure and use a sunscreen
• avoid contact with hair or dyed fabric, including carpet and clothing which may be bleached by this product
• skin irritation may occur, characterized by redness, burning, itching, peeling, or possibly swelling. Mild irritation may be reduced by using the product less frequently or in a lower concentration. If irritation becomes severe, discontinue use; if irritation still continues, consult a doctor.
• using other topical acne medication at the same time or immediately following the use of this product may increase dryness or irritation of the skin. If this occurs, only one medication should be used unless directed by a doctor.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with the eyes. If contact occurs, flush thoroughly with water.

Directions

DOSAGE & ADMINISTRATION SECTION

Cleanse skin thoroughly before applying medication. Cover the entire affected area with a thin layer 1-3 times daily. If bothersome dryness
or peeling occurs, reduce application to once a day.

Other information

SPL UNCLASSIFIED SECTION

Keep tightly closed. Avoid storing at extreme temperatures (below 40° F and above 100° F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

carbomer, disodium EDTA, laureth-4, sodium hydroxide, titanium dioxide, water

Product label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

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 Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71800-044-09ML - Milliliter71800-0443c5ca8fc-c430-4461-bee2-13808cf30ae512025-05-14

Products#

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

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NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71800-04471800-044-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 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.

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
46e0ec6f-7471-b030-e063-6394a90a3fcf1ed5fc07-7bf2-4293-882f-e02423beea7d2025-12-26WarningsExact identifier
spl id: 46e0ec6f-7471-b030-e063-6394a90a3fcf
spl set id: 1ed5fc07-7bf2-4293-882f-e02423beea7d

Reported adverse events (FAERS/openFDA)#

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