FDA.reportPublic FDA data

Prosoria Psoriasis Treatment

Manufacturer
Nuvothera, Inc. | Swiss-American CDMO
Effective date
2024-01-10
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:07:06

Label at a glance#

ProductProsoria Psoriasis Treatment
Active ingredientSalicylic Acid
Label structure11 sections

Indications and uses

relieves and helps prevent recurrence of psoriasis symptoms including: scaling flaking itching redness irritation

Dosage and administration

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

Storage and handling

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

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Salicylic acid, 3%

Purpose

OTC - PURPOSE SECTION

Antipsoriasis

Uses

INDICATIONS & USAGE SECTION

relieves and helps prevent recurrence of psoriasis symptoms including:

  • scaling
  • flaking
  • itching
  • redness
  • irritation

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.

OTC - STOP USE SECTION

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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Citric Acid, Curcuma Longa (Turmeric) Root Extract, Cyclodextrin, Disodium EDTA, Ethoxydiglycol, Polyacrylate Crosspolymer-6, Potassium Sorbate, Oleth-3 Phosphate, Sodium Hydroxide, Tetrahydrodiferuloylmethane, Water.

Questions?

OTC - QUESTIONS SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

prosoria

MAXIMUM
STRENGTH

treats

psoriasis
treatment gel
3% salicylic acid

2 FL OZ (59mL)

PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
283602salicylic acid 3 % Topical GelPSN6
283602salicylic acid 0.03 MG/MG Topical GelSCD6
283602salicylic acid 3 % Topical GelSY6

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71573-102-01Prosoria Psoriasis Treatment59 mL in 1 BOTTLE, PLASTICGEL596
71573-102-08Prosoria Psoriasis Treatment118 mL in 1 BOTTLE, PLASTICGEL1186

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71573-102PROSORIA PSORIASIS TREATMENT (SALICYLIC ACID) GEL [NUVOTHERA, INC.]6Current NDC, Legacy NDC, 2 package rows20240112_f94f4481-c58e-4555-9863-cbaa2c4cdd07.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71573-10271573-102-01, 71573-102-08

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
Salicylic AcidO414PZ4LPZACTIB
Water059QF0KO0RIACT
Diethylene Glycol Monoethyl EtherA1A1I8X02BIACT
Tetrahydrodiferuloylmethane00U0645U03IACT
TURMERIC856YO1Z64FIACT
GAMMA CYCLODEXTRINKZJ0BYZ5VAIACT
Oleth-3 Phosphate8Q0Z18J1VLIACT
Edetate Disodium Anhydrous8NLQ36F6MMIACT
Sodium Hydroxide55X04QC32IIACT
Potassium HydroxideWZH3C48M4TIACT
Potassium Sorbate1VPU26JZZ4IACT
Citric Acid Monohydrate2968PHW8QPIACT

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.378311aa-95f7-4c69-bc00-e688468262bd2026-08-18WarningsExact identifier
ndc (package): 71573-102-01
ndc11 (package): 71573010201
Prosoria Psoriasis TreatmentSALICYLIC ACIDNuvothera, Inc.f94f4481-c58e-4555-9863-cbaa2c4cdd072024-01-10WarningsExact identifier
ndc (package): 71573-102-01
ndc (package): 71573-102-08
ndc (product): 71573-102
ndc11 (package): 71573010208
ndc11 (package): 71573010201
spl id: cdff94ae-4a19-40d1-9e9f-8caa42577394
spl set id: f94f4481-c58e-4555-9863-cbaa2c4cdd07

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.