PROSORIA SCALP- salicylic acid lotion/shampoo 
Nuvothera, Inc.

----------

Prosoriä Scalp Lotion

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:

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

Other information

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.

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
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)

Revised: 1/2024
Document Id: b35202c5-6f8b-4013-b720-becfc5fe97db
Set id: 52a98715-3e57-4b86-b91e-0ce433dc22bd
Version: 2
Effective Time: 20240110
 
Nuvothera, Inc.