ACNE TREATMENT- benzoyl peroxide gel

Acne Treatment by

Drug Labeling and Warnings

Acne Treatment by is a Otc medication manufactured, distributed, or labeled by Topco associates LLC, Vi-Jon, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredients

Benzoyl peroxide 10%

Purpose

Acne medication

Use

for the treatment of acne

Warnings

For external use only

Do not use if you

• have very sensitive skin
• are sensitive to benzoyl peroxide

When using this product

• 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 posible swelling. Irritation may be reduced by using the product less frequently or in a lower concentration

stop use and ask a doctor if

irritation becomes severe

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• 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

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

Questions 

1-888-423-0139

Disclaimer

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

Adverse Reaction

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

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)

INGREDIENTS AND APPEARANCE

ACNE TREATMENT 
benzoyl peroxide gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76162-229
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM)	BENZOYL PEROXIDE	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
EDETATE DISODIUM (UNII: 7FLD91C86K)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
LAURETH-4 (UNII: 6HQ855798J)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76162-229-10	1 in 1 PACKAGE	08/23/2022
1		28 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M006	08/23/2022

Labeler - Topco associates LLC (006935977)

Registrant - Consumer Product Partners, LLC (119091520)

Establishment
Name	Address	ID/FEI	Business Operations
Consumer Product Partners, LLC		119091514	manufacture(76162-229)

Establishment
Name	Address	ID/FEI	Business Operations
Fidelitone Order Fulfillment		117825116	pack(76162-229)