Prosoriä Scalp Lotion

Manufacturer
Nuvothera, Inc. | Swiss-American CDMO
Effective date
2024-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:01

Label at a glance#

ProductProsoria Scalp
Active ingredientSalicylic Acid
Label structure11 sections

Indications and uses

relieves and helps prevent recurrence of symptoms of psoriasis and/or seborrheic dermatitis including: scaling flaking itching redness irritation

Dosage and administration

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.

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, 1.8%

Purpose

OTC - PURPOSE SECTION

Antipsoriasis, antiseborrheic

Uses

INDICATIONS & USAGE SECTION

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

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 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

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

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?

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, Texas 76104

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

treats

prosoriä

scalp lotion

1.8% salicylic acid

anti-psoriasis
anti-seborrheic

2.5 FL OZ (74mL)

PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 74 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
244525salicylic acid 1.8 % Topical LotionPSN2
244525salicylic acid 18 MG/ML Topical LotionSCD2
244525salicylic acid 1.8 % Topical LotionSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71573-116-09Prosoria Scalp74 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO742

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71573-116PROSORIA SCALP (SALICYLIC ACID) LOTION/SHAMPOO [NUVOTHERA, INC.]2Current NDC, Legacy NDC, 1 package rows20240112_52a98715-3e57-4b86-b91e-0ce433dc22bd.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71573-11671573-116-09

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Prosoria ScalpSALICYLIC ACIDNuvothera, Inc.52a98715-3e57-4b86-b91e-0ce433dc22bd2024-01-10WarningsExact identifier
ndc (package): 71573-116-09
ndc (product): 71573-116
ndc11 (package): 71573011609
spl id: b35202c5-6f8b-4013-b720-becfc5fe97db
spl set id: 52a98715-3e57-4b86-b91e-0ce433dc22bd

Reported adverse events (FAERS/openFDA)#

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