Label: PROSORIA PSORIASIS TREATMENT- salicylic acid kit

  • 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 March 8, 2022

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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

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    DERMATOLOGIST TESTED

    prosoriä

    PSORIASIS
    treatment system

    maximum strength
    Salicylic Acid 3% Gel

    plus soothing botanicals and vitamins

    once daily
    2
    STEP KIT
    once daily

    NATIONAL
    PSORIASIS
    FOUNDATION
    RECOGNIZED

    • Once Daily
    • Relieves:
      itching,
      redness &
      irritated
      skin
    • Rapidly
      removes
      scaling &
      flaking
    • Softens &
      moisturizes

    Antioxidant Rich Formula
    turmeric root, curcumin shea butter, vitamin E

    TREATMENT GEL
    2 FL OZ (59mL)

    MOISTURIZING OINTMENT
    NET WT 2OZ (60g)

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    PROSORIA PSORIASIS TREATMENT 
    salicylic acid kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71573-117
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71573-117-031 in 1 CARTON02/18/2022
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOTTLE, PLASTIC 59 mL
    Part 21 TUBE 60 g
    Part 1 of 2
    PROSORIA PSORIASIS TREATMENT 
    salicylic acid gel
    Product Information
    Item 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 Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H11/22/2017
    Part 2 of 2
    EXFOLIATING AND MOISTURIZING 
    other skin care preparations ointment
    Product Information
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRPetrolatum (UNII: 4T6H12BN9U)  
    INGRSHEA BUTTER (UNII: K49155WL9Y)  
    INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
    INGRSalicylic Acid (UNII: O414PZ4LPZ)  
    INGRParaffin (UNII: I9O0E3H2ZE)  
    INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    COSMETIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH FINALpart358H02/18/2022
    Labeler - Nuvothera, Inc. (080499864)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO080170933MANUFACTURE(71573-117)
    Establishment
    NameAddressID/FEIBusiness Operations
    Global Packaging Systems964987890LABEL(71573-117) , PACK(71573-117)
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