Label: PROSORIA PSORIASIS TREATMENT- salicylic acid gel

  • NDC Code(s): 71573-102-01, 71573-102-08
  • Packager: Nuvothera, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 10, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Salicylic acid, 3%

  • Purpose

    Antipsoriasis

  • Uses

    relieves and helps prevent recurrence of psoriasis symptoms including:

    • scaling
    • flaking
    • itching
    • redness
    • irritation
  • Warnings

    For external use only

    When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

    Stop use and consult a doctor if the condition worsens or does not improve after regular use of this product as directed and/or if condition covers a large area of the body.

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply to affected areas once daily or as directed by a doctor
    • use in conjunction with the Prosoria Daily Psoriasis Treatment System.
  • Other information

    • store at room temperature 59-77°F (15-25°C).
  • Inactive ingredients

    Citric Acid, Curcuma Longa (Turmeric) Root Extract, Cyclodextrin, Disodium EDTA, Ethoxydiglycol, Polyacrylate Crosspolymer-6, Potassium Sorbate, Oleth-3 Phosphate, Sodium Hydroxide, Tetrahydrodiferuloylmethane, Water.

  • Questions?

    Visit www.prosoria.com or call toll-free 1-833-776-7483 Mon - Fri, 8am - 5pm CT.

  • SPL UNCLASSIFIED SECTION

    Distributed by Nuvothera, Inc.
    Fort Worth, TX 76104

  • PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

    prosoria

    MAXIMUM
    STRENGTH

    treats

    psoriasis
    treatment gel
    3% salicylic acid

    2 FL OZ (59mL)

    PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PROSORIA PSORIASIS TREATMENT 
    salicylic acid gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71573-102
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid1.77 g  in 59 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    Tetrahydrodiferuloylmethane (UNII: 00U0645U03)  
    TURMERIC (UNII: 856YO1Z64F)  
    GAMMA CYCLODEXTRIN (UNII: KZJ0BYZ5VA)  
    Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Potassium Hydroxide (UNII: WZH3C48M4T)  
    Potassium Sorbate (UNII: 1VPU26JZZ4)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    Product Characteristics
    ColorWHITE (Off White Beige) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71573-102-0159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product11/22/2017
    2NDC:71573-102-08118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph drugM03211/22/2017
    Labeler - Nuvothera, Inc. (080499864)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO080170933MANUFACTURE(71573-102)
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