Acne Treatment System

Manufacturer
Vivier Pharma, Inc. | Dermolab Pharma Ltd
Effective date
2023-10-27
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-05-31 23:58:22

Label at a glance#

ProductAcne Treatment System
Active ingredientBENZOYL PEROXIDE, SALICYLIC ACID
Label structure8 sections

Dosage and administration

• 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic Acid USP 2%

Purpose

OTC - PURPOSE SECTION

Acne treatment

Use

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Ask a doctor before use if you are

OTC - ASK DOCTOR SECTION

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

OTC - WHEN USING SECTION

do not get into eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

excessive skin irritation develops or increases.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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.



Other information

SPL UNCLASSIFIED SECTION

Store at room temperature (15-30°C / 59-86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acrylates Copolymer, Alcohol, Citric Acid, Disodium Cocoamphodiacetate, Disodium Cocoyl Glutamate, DMDM Hydantoin, Ethoxydiglycol, Fragrance, Hexamidine Diisethionate, PEG-7 Glyceryl Cocoate, PEG-120 Methyl Glucose Dioleate, Sodium Hydroxide, Sodium Lauroyl Sarcosinate, Water/Eau.

Questions?

OTC - QUESTIONS SECTION

450 455 9779 1 877 484 8437

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Updated outer boxUpdated outer boxupdated outer box 2updated outer box 230mL Acne Treatment Lotion30mL Acne Treatment Lotion150mL Medicated Wash150mL Medicated Wash

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1092658{1 (30 ML) (benzoyl peroxide 50 MG/ML Topical Lotion) / 1 (150 ML) (salicylic acid 20 MG/ML Medicated Liquid Soap) } PackGPCK8
106309benzoyl peroxide 5 % Topical LotionPSN8
1092658benzoyl peroxide 5 % Topical Lotion (30 ML) / salicylic acid 2 % Medicated Liquid Soap (150 ML) PackPSN8
562600salicylic acid 2 % Medicated Liquid SoapPSN8
106309benzoyl peroxide 50 MG/ML Topical LotionSCD8
562600salicylic acid 20 MG/ML Medicated Liquid SoapSCD8
1092658{1 (150 ML salicylic acid 2 % Medicated Liquid Soap) / 1 (30 ML benzoyl peroxide 5 % Topical Lotion) } PackSY8
106309benzoyl peroxide 5 % Topical LotionSY8
562600salicylic acid 2 % Facial Cleanser TonerSY8
562600salicylic acid 2 % Facial ScrubSY8
562600salicylic acid 2 % Medicated Liquid SoapSY8

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
67226-1021-1Acne Treatment System150 mL in 1 BOTTLE, PUMPLIQUID150 mL20 mg in 1mL8
67226-2050-3Acne Treatment System1 in 1 BOXLOTION50 mg in 1mL8
67226-2050-3Acne Treatment System30 mL in 1 TUBELOTION30 mL50 mg in 1mL8
67226-3026-9Acne Treatment System1 in 1 KITKIT18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
67226-1021ACNE TREATMENT SYSTEM (BENZOYL PEROXIDE, SALICYLIC ACID) KIT [VIVIER PHARMA, INC.]8Current NDC, Legacy NDC20231030_d39ee6a2-5d65-4198-82d9-deb83471f312.zip
67226-2050ACNE TREATMENT SYSTEM (BENZOYL PEROXIDE, SALICYLIC ACID) KIT [VIVIER PHARMA, INC.]8Current NDC, Legacy NDC20231030_d39ee6a2-5d65-4198-82d9-deb83471f312.zip
67226-3026ACNE TREATMENT SYSTEM (BENZOYL PEROXIDE, SALICYLIC ACID) KIT [VIVIER PHARMA, INC.]8Current NDC, Legacy NDC, 4 package rows20231030_d39ee6a2-5d65-4198-82d9-deb83471f312.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
67226-302667226-3026-9
67226-205067226-2050-3
67226-102167226-1021-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 25 matching rows.

Source Document#

Source XML · Source PDF

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 · 3 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Medicated WashSALICYLIC ACIDVivier Pharma, Inc.e90ab8b6-6a77-4e02-9d71-45cd7383cb0a2023-11-14WarningsExact identifier
ndc (package): 67226-1021-1
ndc (product): 67226-1021
ndc11 (package): 67226102101
Acne TreatmentBENZOYL PEROXIDEVivier Pharma, Inc.b4844539-bdd2-42a6-b946-6028de4f3cf12023-10-27WarningsExact identifier
ndc (package): 67226-2050-3
ndc (product): 67226-2050
ndc11 (package): 67226205003
Acne Treatment SystemBENZOYL PEROXIDE, SALICYLIC ACIDVivier Pharma, Inc.d39ee6a2-5d65-4198-82d9-deb83471f3122023-10-27WarningsExact identifier
ndc (package): 67226-2050-3
ndc (package): 67226-3026-9
ndc (package): 67226-1021-1
ndc (product): 67226-3026
ndc11 (package): 67226102101
ndc11 (package): 67226302609
ndc11 (package): 67226205003
spl id: 08bf3bb5-bbeb-99b5-e063-6394a90a8028
spl set id: d39ee6a2-5d65-4198-82d9-deb83471f312

Reported adverse events (FAERS/openFDA)#

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