Label: PROSORIA MEDICATED- selenium sulfide lotion/shampoo

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated January 11, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient

    Selenium sulfide 1%

  • Purpose

    Anti-dandruff, Anti-seborrheic dermatitis

  • Uses

    for the relief of itching, irritation, redness, flaking, scaling associated with dandruff and seborrheic dermatitis.

  • Warnings

    For external use only

    When using this product

    • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
    • if condition worsens or does not improve after regular use of this product as directed, consult a doctor.

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

  • Directions

    • for best results use at least twice a week or as directed by a doctor.
    • for maximum control, use every time you shampoo.
    • shake bottle before use.
    • wet hair, massage onto scalp, rinse, repeat if desired.
  • Other information

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

    Aloe Barbadensis Leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Cocamidopropyl Betaine, Disodium EDTA, D&C YELLOW 10, FD&C RED 40, Guar Hydroxypropyltrimonium Chloride, Panthenol, Phenoxyethanol, Propylene Glycol, Water, Sodium Laureth Sulfate, Stearyl Alcohol, Tocopheryl Acetate, Xanthan Gum.

  • 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 - 177 mL Bottle Label

    treats

    prosoriä

    medicated
    shampoo

    selenium sulfide 1%

    anti-dandruff
    anti-seborrheic

    6 FL OZ (177 mL)

    Principal Display Panel - 177 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    PROSORIA MEDICATED 
    selenium sulfide lotion/shampoo
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71573-121
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Selenium Sulfide (UNII: Z69D9E381Q) (Selenium Sulfide - UNII:Z69D9E381Q) Selenium Sulfide1.77 g  in 177 mL
    Inactive Ingredients
    Ingredient NameStrength
    Water (UNII: 059QF0KO0R)  
    Cetyl alcohol (UNII: 936JST6JCN)  
    GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)  
    Aloe Vera Leaf (UNII: ZY81Z83H0X)  
    Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
    Cocamidopropyl Betaine (UNII: 5OCF3O11KX)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    Panthenol (UNII: WV9CM0O67Z)  
    Propylene Glycol (UNII: 6DC9Q167V3)  
    Stearyl Alcohol (UNII: 2KR89I4H1Y)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Xanthan Gum (UNII: TTV12P4NEE)  
    Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)  
    Phenoxyethanol (UNII: HIE492ZZ3T)  
    Product Characteristics
    ColorORANGEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71573-121-12177 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
    Quality CDMO117658386MANUFACTURE(71573-121)
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