PROSORIA MEDICATED- selenium sulfide lotion/shampoo 
Nuvothera, Inc.

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Prosoria Medicated Shampoo

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

Other information

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.

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
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)

Revised: 1/2024
Document Id: 6fec05aa-5d44-4667-98f7-c61ac09c6307
Set id: 44eaaeb0-1400-4697-85d0-e8c2282c1cba
Version: 2
Effective Time: 20240111
 
Nuvothera, Inc.