PROSORIA SCALP- salicylic acid lotion/shampoo

Prosoria Scalp by

Drug Labeling and Warnings

Prosoria Scalp 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, 1.8%

Purpose

Antipsoriasis, antiseborrheic

Uses

relieves and helps prevent recurrence of symptoms of psoriasis and/or seborrheic dermatitis 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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• apply and massage well on affected areas of the scalp once daily or as directed by a doctor. Tip bottle and apply small drops to affected area of the scalp and spread evenly. Let dry and leave on. Shampoo hair when needed.

Other information

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

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.

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

PROSORIA SCALP 
salicylic acid lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71573-116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	1.33 g  in 74 mL

Inactive Ingredients
Ingredient Name	Strength
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
Color	YELLOW (Off White Light Yellow)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71573-116-09	74 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	04/01/2022

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M032	04/01/2022

Labeler - Nuvothera, Inc. (080499864)

Establishment
Name	Address	ID/FEI	Business Operations
Swiss-American CDMO		080170933	MANUFACTURE(71573-116)