Label: PROSORIA SCALP- salicylic acid lotion/shampoo

  • 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, 1.8%

  • Purpose

    Antipsoriasis, antiseborrheic

  • Uses

    relieves and helps prevent recurrence of symptoms of psoriasis and/or seborrheic dermatitis 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.

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

  • Directions

    • apply and massage well on affected areas of the scalp once daily or as directed by a doctor. Tip bottle and apply small drops to affected area of the scalp and spread evenly. Let dry and leave on. Shampoo hair when needed.
  • Other information

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

    Water, Petrolatum, Ethoxydiglycol, Oleth-3 Phosphate, Butylene Glycol, Tetrahydrodiferuloylmethane, Polyacrylate Crosspolymer-6, Sodium Hydroxide, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Curcuma Longa (Turmeric) Root Extract, Nigella Sativa Seed Oil, Polyisobutene, Cyclodextrin, Undecylenoyl Glycine, Phenoxyethanol, Capryloyl Glycine, Disodium EDTA, PEG-7 Trimethylolpropane Coconut Ether, Tocopheryl Acetate, Citric Acid.

  • 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, Texas 76104

  • PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label

    treats

    prosoriä

    scalp lotion

    1.8% salicylic acid

    anti-psoriasis
    anti-seborrheic

    2.5 FL OZ (74mL)

    PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PROSORIA SCALP 
    salicylic acid lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71573-116
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ) Salicylic Acid1.33 g  in 74 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)  
    AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) (UNII: Q7UI015FF9)  
    Tetrahydrodiferuloylmethane (UNII: 00U0645U03)  
    TURMERIC (UNII: 856YO1Z64F)  
    Petrolatum (UNII: 4T6H12BN9U)  
    Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    Sodium Hydroxide (UNII: 55X04QC32I)  
    Butylene Glycol (UNII: 3XUS85K0RA)  
    Nigella Sativa Seed Oil (UNII: CS4U38E731)  
    Citric Acid Monohydrate (UNII: 2968PHW8QP)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYISOBUTYLENE (1300 MW) (UNII: 241BN7J12Y)  
    BETADEX (UNII: JV039JZZ3A)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) (UNII: 86FQE96TZ4)  
    Undecylenoyl Glycine (UNII: 4D20464K2J)  
    Capryloyl Glycine (UNII: 8TY5YO42NJ)  
    PEG-7 Trimethylolpropane Coconut Ether (UNII: MVJ3AD73GG)  
    Product Characteristics
    ColorYELLOW (Off White Light Yellow) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71573-116-0974 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/01/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM03204/01/2022
    Labeler - Nuvothera, Inc. (080499864)
    Establishment
    NameAddressID/FEIBusiness Operations
    Swiss-American CDMO080170933MANUFACTURE(71573-116)
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