Drugplain

Acne Treatment 100 mg/g

Benzoyl peroxide · GEL · Topco Associates LLC

10 Recalls on RecordCurrently in Shortage
Plain English

Acne Treatment is a gel containing benzoyl peroxide at 100 mg/g, taken topical. Manufactured by Topco Associates LLC.

Key Facts

Brand Name
Acne Treatment
Generic Name
Benzoyl peroxide
NDC Code (Product)
76162-229
Manufacturer
Topco Associates LLC
Strength
100 mg/g
Dosage Form
GEL
Route
TOPICAL
Marketing Status
Application #
M006
Marketing Start
08/23/2022

Recall History

10 Recalls on Record
Class III03/20/2017

Valeant Pharmaceuticals North America LLC

Discoloration.

TerminatedVoluntary: Firm initiated
Class II03/11/2025

Fruit Of The Earth, Inc.

Chemical contamination: presence of benzene

OngoingVoluntary: Firm initiated
Class III05/07/2012

Guthy-Renker LLC

Subpotent Drug: Salicylic acid is subpotent.

TerminatedVoluntary: Firm initiated
Class II03/03/2026

Owen Biosciences Inc.

Chemical contamination: Presence of benzene

OngoingVoluntary: Firm initiated
Class III07/06/2020

Allergan PLC

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

TerminatedVoluntary: Firm initiated
Class III07/06/2020

Allergan PLC

SUBPOTENT DRUG: Products failed assay results at the 12 and 24 month timepoints.

TerminatedVoluntary: Firm initiated
Class III04/01/2014

Genesis Pharmaceutical, Inc.

Failed Stability Specifications: Out of specification results for viscosity in one lot of Glytone Acne Treatment Facial Cleanser.

TerminatedVoluntary: Firm initiated
Class II02/24/2025

Denison Pharmaceuticals, LLC

Chemical Contamination: Presence of benzene.

OngoingVoluntary: Firm initiated
Class II03/05/2025

L'Oreal USA

cGMP Deviations: The recall was initiated due to detected trace levels of benzene in a specific lot of this product lot (MYX46W), however out of an abundance of caution, the firm voluntarily recalled all La Roche-Posay Effaclar Duo Dual Action Acne Treatment lots.

OngoingVoluntary: Firm initiated
Class III08/03/2018

Huijing (Shanghai) Bio-tech Co., Ltd.

Subpotent drug: The product active ingredient level not matching the exact levels indicated on the packaging label.

TerminatedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

drug ineffective53,195 reports
dry skin45,373 reports
skin burning sensation41,878 reports
acne39,418 reports
erythema38,598 reports
skin irritation26,461 reports
skin exfoliation21,372 reports
inappropriate schedule of product administration16,244 reports
rash15,899 reports
overdose13,251 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Stop use and ask a doctor if irritation becomes severe.

Dosage & Administration

Acne Cleanser Directions: Cleanse twice a day. Wet face. Apply to hands, add water and work into lather. Massage Face gently. Rinse thoroughly.

Warnings

Acne Cleanser Warnings: For external use only 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 medication at a time. Avoid contact with eyes, If contact occurs, flush thoroughly with water.

Frequently Asked Questions

What is Acne Treatment used for?

Acne Treatment contains Benzoyl peroxide. It is a gel taken topical. Consult your doctor for specific uses.

Is Acne Treatment a controlled substance?

Acne Treatment is not classified as a controlled substance by the DEA.

What is the generic name for Acne Treatment?

The generic name for Acne Treatment is Benzoyl peroxide. There are 12 other brand versions of Benzoyl peroxide.

What is the NDC code for Acne Treatment 100 mg/g?

The NDC (National Drug Code) for Acne Treatment 100 mg/g is 76162-229, listed by Topco Associates LLC.