Label: ATRIX CLARIFYING TONER- salicylic acid liquid

  • 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 January 11, 2023

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 acne pimples, acne blemishes, whiteheads and blackheads

  • Warnings

    For external use only.

    Flammable: Keep away from fire or flame.

    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 product ■ moisten a cotton ball and 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 20° to 25°C (68° to 77°F)
    [see USP Controlled Room Temperature].

  • QUESTIONS

    Questions? Call toll-free:
    1-877-921-7873

  • Inactive ingredients

    Aqua (Purified Water), Benzalkonium Chloride, Benzyl Alcohol, Citrus Paradisi (Grapefruit) Peel Oil, Ethoxydiglycol, Ethyl Alcohol, Glycerin, Menthol, Menthyl Lactate, Pyrus Malus (Apple) Fruit Extract, Rosmarinus Officinalis (Rosemary) Leaf Extract, Sambucus Nigra (Elderberry) Fruit Extract, Sodium Hydroxide.

  • Atrix™ Clarifying Toner

    Manufactured in the USA by:
    PureTek Corporation
    Panorama City, CA 91402

    Label

  • INGREDIENTS AND APPEARANCE
    ATRIX CLARIFYING TONER 
    salicylic acid liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59088-444
    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)  
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    GRAPEFRUIT OIL (UNII: YR377U58W9)  
    DIETHYLENE GLYCOL MONOETHYL ETHER (UNII: A1A1I8X02B)  
    ALCOHOL (UNII: 3K9958V90M)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MENTHOL, UNSPECIFIED FORM (UNII: L7T10EIP3A)  
    MENTHYL LACTATE, (-)- (UNII: 2BF9E65L7I)  
    APPLE (UNII: B423VGH5S9)  
    ROSEMARY (UNII: IJ67X351P9)  
    EUROPEAN ELDERBERRY (UNII: BQY1UBX046)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59088-444-08118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/05/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333D01/05/2021
    Labeler - PureTek Corporation (785961046)
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