PROSORIA PSORIASIS TREATMENT- salicylic acid gel

Prosoria Psoriasis Treatment by

Drug Labeling and Warnings

Prosoria Psoriasis Treatment by is a Otc medication manufactured, distributed, or labeled by Nuvothera, Inc., Swiss-American CDMO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic acid, 3%

Purpose

Antipsoriasis

Uses

relieves and helps prevent recurrence of psoriasis symptoms including:

• scaling
• flaking
• itching
• redness
• irritation

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

• apply to affected areas once daily or as directed by a doctor
• use in conjunction with the Prosoria Daily Psoriasis Treatment System.

Other information

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

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.

SPL UNCLASSIFIED SECTION

Distributed by Nuvothera, Inc.
Fort Worth, TX 76104

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

prosoriä

treats

2
psoriasis treatment gel
3% salicylic acid

daily psoriasis
treatment system

2 FL OZ (59mL)

INGREDIENTS AND APPEARANCE

PROSORIA PSORIASIS TREATMENT 
salicylic acid gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71573-102
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	1.77 g  in 59 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	WHITE (Off White Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71573-102-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	11/22/2017
2	NDC: 71573-102-08	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	02/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part358H	11/22/2017

Labeler - Nuvothera, Inc. (080499864)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO		080170933	MANUFACTURE(71573-102) , LABEL(71573-102) , PACK(71573-102) , ANALYSIS(71573-102)