Label: ATRIX ACNE TREATMENT- salicylic acid cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated April 6, 2021

If you are a consumer or patient 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
    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)  
    GLUCOSAMINE HYDROCHLORIDE (UNII: 750W5330FY)  
    HEXYLENE GLYCOL (UNII: KEH0A3F75J)  
    OLIGOPEPTIDE-10 (UNII: Q46328TRNK)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    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)  
    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 finalpart333D04/06/2021
    Labeler - PureTek Corporation (785961046)