Maximum Strength Acne

Manufacturer
TopCare | Product Quest Mfg
Effective date
2018-06-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:56:04

Label at a glance#

ProductMaximum Strength Acne
Active ingredientBenzoyl Peroxide
Label structure6 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                                      Purpose
Benzoyl Peroxide 10%.............................Acne Treatment

INDICATIONS & USAGE SECTION

Uses for the treatment of acne

WARNINGS SECTION

Warnings
For external use only.
Do not use if you have very sensitive skin or are sensitive to benzoyl peroxide.
When using this product • 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. • rinse right away with water if it gets in eyes • 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 skin irritation becomes severe.
Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center
right away

DOSAGE & ADMINISTRATION SECTION

Directions • cleanse the skin thoroughly before applying medication • cover the entire
affected area with a thin layer one to three times a day • because excessive drying of the skin
may occur, start with one application daily, then gradually increase to two or 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, use a sunscreen. Allow product
to dry, then follow direction in the sunscreen labeling. If sensitivity develops, discontinue use of
both products and consult a doctor.

INACTIVE INGREDIENT SECTION

Inactive ingredients Carbomer, Disodium EDTA, Disodium Lauryl Sulfosuccinate,
Methylparaben, Sodium Hydroxide, Water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage descriptionimage descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
486131benzoyl peroxide 10 % Topical GelPSN1
486131benzoyl peroxide 0.1 MG/MG Topical GelSCD1
486131benzoyl peroxide 10 % Topical GelSY1

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
36800-878-012020-01-31C16284748780-19d75b9d1-01d4-f424-e053-dadaa90a57ceDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-878-01Maximum Strength Acne28 g in 1 BOTTLEGEL281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-878MAXIMUM STRENGTH ACNE (BENZOYL PEROXIDE 10%) GEL [TOPCARE]1Legacy NDC, 1 package rows20180625_e71eb901-8d52-4313-910b-fb8afa0da99f.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-87836800-878-01

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
d554ecdc-959d-4a96-89e0-0c8c5eb45678e71eb901-8d52-4313-910b-fb8afa0da99f2018-06-25WarningsExact identifier
spl id: d554ecdc-959d-4a96-89e0-0c8c5eb45678
spl set id: e71eb901-8d52-4313-910b-fb8afa0da99f

Reported adverse events (FAERS/openFDA)#

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