Label: ACNE TREATMENT SYSTEM- benzoyl peroxide, salicylic acid kit

  • NDC Code(s): 67226-1021-1, 67226-2050-3, 67226-3026-9
  • Packager: Vivier Pharma, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 27, 2023

If you are a consumer or patient please visit this version.

View All Sections
  • Drug facts

  • Active ingredient

    Salicylic Acid USP 2%

    Purpose

    Acne treatment

  • Use

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

  • 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.

  • 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.



  • Other information

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

  • Inactive ingredients

    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?

    450 455 9779 1 877 484 8437

  • Package Labeling:

    Updated outer boxupdated outer box 230mL Acne Treatment Lotion150mL Medicated Wash

  • INGREDIENTS AND APPEARANCE
    ACNE TREATMENT SYSTEM 
    benzoyl peroxide, salicylic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67226-3026
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-3026-91 in 1 KIT11/11/2017
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 30 mL
    Part 21 BOTTLE, PUMP 150 mL
    Part 1 of 2
    ACNE TREATMENT 
    benzoyl peroxide lotion
    Product Information
    Item Code (Source)NDC:67226-2050
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOYL PEROXIDE (UNII: W9WZN9A0GM) (BENZOYL PEROXIDE - UNII:W9WZN9A0GM) BENZOYL PEROXIDE50 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    LANOLIN OIL (UNII: OVV5IIJ58F)  
    LAURETH-4 (UNII: 6HQ855798J)  
    LAURETH-7 (UNII: Z95S6G8201)  
    MAGNESIUM ALUMINUM SILICATE (UNII: 6M3P64V0NC)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-2050-31 in 1 BOX
    130 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/01/2011
    Part 2 of 2
    MEDICATED WASH 
    salicylic acid liquid
    Product Information
    Item Code (Source)NDC:67226-1021
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) (UNII: JZ1374NL9E)  
    ALCOHOL (UNII: 3K9958V90M)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    DISODIUM COCOYL GLUTAMATE (UNII: MBK0CP8F5A)  
    DMDM HYDANTOIN (UNII: BYR0546TOW)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    HEXAMIDINE DIISETHIONATE (UNII: 023XA5Z50L)  
    PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
    PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67226-1021-1150 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/11/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00611/11/2017
    Labeler - Vivier Pharma, Inc. (250996550)
    Establishment
    NameAddressID/FEIBusiness Operations
    Dermolab Pharma Ltd245414743manufacture(67226-3026, 67226-2050, 67226-1021)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!