FDA.reportPublic FDA data

Top Care 229.001/229AC-AD 10% Benzoyl Peroxide Acne Medicated Gel

Manufacturer
Topco Associates LLC | Nice-Pak Products, LLC
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:44:21

Label at a glance#

ProductAcne Treatment
Active ingredientBENZOYL PEROXIDE
Label structure14 sections

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 or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce daily application to once a day or every other day if going outside, ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Benzoyl peroxide 10%

Purpose

OTC - PURPOSE SECTION

Acne medication

Use

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 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 aother 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 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 possible 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

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 or three times daily if needed or as directed by a doctor
  • if bothersome dryness or peeling occurs, reduce daily 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

carbomer, disodium EDTA, hydroxypropyl methylcellulose, laureth-4, sodium hydroxide, water

Questions 

OTC - QUESTIONS SECTION

1-888-423-0139

Disclaimer

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Kenvue, Inc., distributor of Clean & Clear ®Persa-Gel ®10 Maximum Strength.

Adverse Reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY TOPCO ASSOCIATES LLC

Itasca, IL 60143 ©TOPCO VIJA0424

QUESTIONS? 1-888-423-0139

topcare@topco.com

www.topcarebrand.com

Quality Guaranteed

Scan here for more information or call 1-888-423-0139

principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TopCare ®Beauty

ACNE TREATMENT

10% Benzoyl Peroxide

Compare to CLEAN & CLEAR ®Persa-Gel ®10*

Maximum strength benzoyl peroxide acne medication available under the product monograph

This micronized benzoyl peroxide formula goes to work releasing the medicine deep into the pore where pimples begin.

Dermatologist Tested

PARABEN & PHTHALATE FREE

Fragrance Free

NET WT 1 OZ (28 g)

package contains one tube

not actual size

NET WT 1 OZ (28 g)

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
486131benzoyl peroxide 10 % Topical GelPSN6
486131benzoyl peroxide 0.1 MG/MG Topical GelSCD6
486131benzoyl peroxide 10 % Topical GelSY6

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
76162-229-10Acne Treatment28 g in 1 TUBEGEL286
76162-229-10Acne Treatment1 in 1 PACKAGEGEL16

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
76162-22976162-229-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
EDETATE DISODIUM7FLD91C86KIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
LAURETH-46HQ855798JIACT
SODIUM HYDROXIDE55X04QC32IIACT
WATER059QF0KO0RIACT
BENZOYL PEROXIDEW9WZN9A0GMACTIB

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
Acne TreatmentBENZOYL PEROXIDETopco Associates LLC8d5e7e40-5e61-470a-b8ff-0b2dca3cabb02026-02-13Warnings, Adverse reactionsExact identifier
ndc (package): 76162-229-10
ndc (product): 76162-229
ndc11 (package): 76162022910
spl id: 4ab82269-281c-d203-e063-6394a90ae996
spl set id: 8d5e7e40-5e61-470a-b8ff-0b2dca3cabb0

Reported adverse events (FAERS/openFDA)#

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