PROSORIA PSORIASIS TREATMENT- salicylic acid gel 
Nuvothera, Inc.

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Prosoria Psoriasis Treatment

Drug Facts

Active ingredient

Salicylic acid, 3%

Purpose

Antipsoriasis

Uses

relieves and helps prevent recurrence of psoriasis symptoms 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 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

Other information

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.

Distributed by Nuvothera, Inc.
Fort Worth, TX 76104

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

prosoria

MAXIMUM
STRENGTH

treats

psoriasis
treatment gel
3% salicylic acid

2 FL OZ (59mL)

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
PROSORIA PSORIASIS TREATMENT 
salicylic acid gel
Product Information
Product TypeHUMAN OTC DRUGItem 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 Product11/22/2017
2NDC:71573-102-08118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/01/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph drugM03211/22/2017
Labeler - Nuvothera, Inc. (080499864)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO080170933MANUFACTURE(71573-102)

Revised: 1/2024
Document Id: cdff94ae-4a19-40d1-9e9f-8caa42577394
Set id: f94f4481-c58e-4555-9863-cbaa2c4cdd07
Version: 6
Effective Time: 20240110
 
Nuvothera, Inc.