Drugplain

Acne Treatment System

BENZOYL PEROXIDE, SALICYLIC ACID · KIT · Vivier Pharma, Inc.

3 Recalls on RecordCurrently in Shortage
Plain English

This over-the-counter acne treatment system contains benzoyl peroxide and salicylic acid, two common ingredients that work to reduce acne-causing bacteria and unclog pores. It comes as a kit that you can use at home as directed on the package.

Key Facts

Brand Name
Acne Treatment System
Generic Name
BENZOYL PEROXIDE, SALICYLIC ACID
NDC Code (Product)
67226-3026
Manufacturer
Vivier Pharma, Inc.
Dosage Form
KIT
Marketing Status
Application #
M006
Marketing Start
11/11/2017

Recall History

3 Recalls on Record
Class II01/10/2014

Dermamedics, L.L.C.

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

TerminatedVoluntary: Firm initiated
Class II01/10/2014

Dermamedics, L.L.C.

Marketed without an Approved NDA/ANDA: FDA has determined that the products are unapproved new drugs and misbranded.

TerminatedVoluntary: Firm initiated
Class III03/20/2017

Valeant Pharmaceuticals North America LLC

Discoloration.

TerminatedVoluntary: Firm initiated

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

Use For the treatment of acne. Dries, clears and helps keep skin clear of new acne pimples, blackheads and whiteheads.

Dosage & Administration

Directions • Wet face using lukewarm water. • Gently massage over face using fingertips. • Rinse completely. • Use both morning and night or as directed by a physician. • If dryness or peeling occurs, reduce application to once a day or every other day.

Warnings

Warnings For external use only. Ask a doctor before use if you are using other topical acne medications at the same time or immediately following 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. When using this product do not get into eyes. Stop use and ask a doctor if excessive skin irritation develops or increases. Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Frequently Asked Questions

What is Acne Treatment System used for?

This over-the-counter acne treatment system contains benzoyl peroxide and salicylic acid, two common ingredients that work to reduce acne-causing bacteria and unclog pores. It comes as a kit that you can use at home as directed on the package.

Is Acne Treatment System a controlled substance?

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

What is the generic name for Acne Treatment System?

The generic name for Acne Treatment System is BENZOYL PEROXIDE, SALICYLIC ACID. There are no other listed brand versions of BENZOYL PEROXIDE, SALICYLIC ACID.

What is the NDC code for Acne Treatment System ?

The NDC (National Drug Code) for Acne Treatment System is 67226-3026, listed by Vivier Pharma, Inc..

Product NDC

67226-3026

Package NDC

67226-3026-9

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

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