PROSORIA PSORIASIS TREATMENT- salicylic acid 
Nuvothera, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Prosoria Psoriasis Treatment System

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

PRINCIPAL DISPLAY PANEL - Kit Carton

DERMATOLOGIST TESTED

prosoriä

PSORIASIS
treatment system

maximum strength
Salicylic Acid 3% Gel

plus soothing botanicals and vitamins

once daily
2
STEP KIT
once daily

NATIONAL
PSORIASIS
FOUNDATION
RECOGNIZED

Antioxidant Rich Formula
turmeric root, curcumin shea butter, vitamin E

TREATMENT GEL
2 FL OZ (59mL)

MOISTURIZING OINTMENT
NET WT 2OZ (60g)

PRINCIPAL DISPLAY PANEL - Kit Carton
PROSORIA PSORIASIS TREATMENT 
salicylic acid kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71573-117
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71573-117-031 in 1 CARTON02/18/2022
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE, PLASTIC 59 mL
Part 21 TUBE 60 g
Part 1 of 2
PROSORIA PSORIASIS TREATMENT 
salicylic acid gel
Product Information
Item 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 Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H11/22/2017
Part 2 of 2
EXFOLIATING AND MOISTURIZING 
other skin care preparations ointment
Product Information
Route of AdministrationTOPICAL
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRPetrolatum (UNII: 4T6H12BN9U)  
INGRSHEA BUTTER (UNII: K49155WL9Y)  
INGRALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)  
INGRSalicylic Acid (UNII: O414PZ4LPZ)  
INGRParaffin (UNII: I9O0E3H2ZE)  
INGR.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
COSMETIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart358H02/18/2022
Labeler - Nuvothera, Inc. (080499864)
Establishment
NameAddressID/FEIBusiness Operations
Swiss-American CDMO080170933MANUFACTURE(71573-117)
Establishment
NameAddressID/FEIBusiness Operations
Global Packaging Systems964987890LABEL(71573-117) , PACK(71573-117)

Revised: 3/2022
Document Id: 8763d64b-b32d-48b2-87e1-d21411eb3bf9
Set id: 378311aa-95f7-4c69-bc00-e688468262bd
Version: 2
Effective Time: 20220308
 
Nuvothera, Inc.