Label: ATRIX SYSTEM 1- salicylic acid kit

  • NDC Code(s): 59088-445-08, 59088-446-05, 59088-713-00
  • Packager: PureTek Corporation
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated October 19, 2021

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

  • Atrix™ Acne Treatment Cream (2 fl oz ) 59 mL

  • Drug Facts

  • Active ingredient

    Salicylic Acid 2%

  • Purpose

    Acne Treatment

  • Uses:

    ■ for the treatment of acne
    ■ dries and clears acne pimples, acne blemishes, whiteheads and blackheads
    ■ helps prevent the development of new acne pimples, acne blemishes, whiteheads and blackheads

  • 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 acne medication at a time.

    ■ rinse right away with water if it gets in eyes.

    Stop use and ask a doctor

    ■ if skin irritation occurs or gets worse

    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 application to once a day or every other day.

    Use under the direction of a medical practitioner.

  • Other information

    ■ protect from freezing

    ■ avoid excessive heat

    Store at 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature].
    Avoid excessive heat. Do not use if package is damaged.
    Keep this and all medication out of reach of children.

  • Inactive ingredients

    Allyl Methacrylates Crosspolymer, Aqua (Purified Water), Butylene Glycol, Caprylyl Glycol, Carbomer, Cetearyl Olivate, Cyclopentasiloxane, Decyl Glucoside, Dimethicone, Dipotassium Glycyrrhizinate, Disodium EDTA, Ethylhexylglycerin, Alpha-Glucan Oligosaccharide, Glucosamine HCl, Glycerin, Glyceryl Stearate SE, Hexylene Glycol, Laminaria Digitata (Algae) Extract, Oligopeptide- 10, Palmitic Acid, Phenoxyethanol, Polysilicone-11, Saccharomyces Cerevisiae Extract, Sodium Ascorbyl Phosphate, Sodium Hydroxide, Sorbitan Olivate, Stearic Acid, DL- alpha- Tocopheryl Acetate, Urea

  • QUESTIONS

    Call toll-free:

    1-877-921-7873

  • Atrix™ Antibacterial Wash (4 fl oz ) 118 mL

  • Active ingredient

    Salicylic Acid 2%

  • Purpose

    Acne treatment

  • Use

    ■ for the treatment of acne

    ■ dries and clears acne pimples, acne blemishes, whiteheads, and blackheads

    ■ helps prevent the development of new acne pimples, acne blemishes, whiteheads, and blackheads

  • 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 acne medication at a time.

    ■ rinse right away with water if it gets in eyes.

    Stop use and ask a doctor

    ■ if skin irritation occurs or gets worse

    Keep out of reach of children.

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

  • Directions

    ■ Cleanse twice a day.

    ■ Wet face. Apply to hands, add water and work into a lather.

    ■ Massage face gently.
    ■ Rinse thoroughly and pat dry if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

    Use under the direction of a medical practitioner.

  • Other information

    ■ protect from freezing

    ■ avoid excessive heat

    Store at 20° to 25°C (68° to 77°F)
    [see USP Controlled Room Temperature].

  • Inactive ingredients

    Aqua (Purified Water), Cetyl Hydroxyethylcellulose, Citrus Paradisi (Grapefruit) Peel Oil, Cocamidopropyl Betaine, Disodium EDTA, Ethoxydiglycol, Glycerin, Lauryl Glucoside, Menthol, Menthyl Lactate, Pyrus Malus (Apple) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sambucus Nigra (Elderberry) Fruit Extract, Sodium Lauryl Glucose Carboxylate.

  • Questions?

    Call toll-free:

    1-877-921-7873

  • Atrix™ System

    Label

  • INGREDIENTS AND APPEARANCE
    ATRIX SYSTEM 1 
    salicylic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-713
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-713-001 in 1 KIT; Type 0: Not a Combination Product10/25/2021
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 TUBE 59 mL
    Part 21 BOTTLE 118 mL
    Part 1 of 2
    ATRIX ACNE TREATMENT 
    salicylic acid cream
    Product Information
    Item Code (Source)NDC:59088-446
    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
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    UREA (UNII: 8W8T17847W)  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: B9J55EA6QX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-446-0559 mL in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D04/06/2021
    Part 2 of 2
    ATRIX ANTIBACTERIAL WASH 
    salicylic acid liquid
    Product Information
    Item Code (Source)NDC:59088-445
    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
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    APPLE (UNII: B423VGH5S9)  
    ROSEMARY (UNII: IJ67X351P9)  
    .ALPHA.-IONENE (UNII: B2ZN1K7W3Q)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
    WATER (UNII: 059QF0KO0R)  
    CETYL HYDROXYETHYLCELLULOSE (350000 MW) (UNII: T7SWE4S2TT)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    SODIUM LAURYL GLYCOL CARBOXYLATE (UNII: 8L0472VMYL)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-445-08118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other10/25/2021
    Labeler - PureTek Corporation (785961046)