Label: ATRIX ACNE TREATMENT- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 1, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • 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 Acne Cream

    Packaged for :
    PureTek Corporation
    Panorama City, CA 91402
    For questions or information
    call toll-free: 877-921-7873

    Label

  • INGREDIENTS AND APPEARANCE
    ATRIX ACNE TREATMENT 
    salicylic acid cream
    Product Information
    Product TypeHUMAN OTC DRUGItem 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
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL STEARATE SE (UNII: FCZ5MH785I)  
    LAMINARIA DIGITATA (UNII: 15E7C67EE8)  
    DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) (UNII: 9E4CO0W6C5)  
    .ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)  
    CETEARYL OLIVATE (UNII: 58B69Q84JO)  
    DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
    SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN OLIVATE (UNII: MDL271E3GR)  
    PALMITIC ACID (UNII: 2V16EO95H1)  
    WATER (UNII: 059QF0KO0R)  
    UREA (UNII: 8W8T17847W)  
    CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
    ALLYL METHACRYLATE/GLYCOL DIMETHACRYLATE CROSSPOLYMER (UNII: B9J55EA6QX)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    .ALPHA.-GLUCAN OLIGOSACCHARIDE (UNII: S95658MI3W)  
    SODIUM ASCORBYL PHOSPHATE (UNII: 836SJG51DR)  
    GLYCYRRHIZINATE DIPOTASSIUM (UNII: CA2Y0FE3FX)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-446-0559 mL in 1 TUBE; Type 0: Not a Combination Product04/06/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00604/06/2021
    Labeler - PureTek Corporation (785961046)