FDA.reportPublic FDA data

Prosoria Medicated

Manufacturer
Nuvothera, Inc. | Quality CDMO
Effective date
2024-01-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:07:01

Label at a glance#

ProductProsoria Medicated
Active ingredientSelenium Sulfide
Label structure11 sections

Indications and uses

for the relief of itching, irritation, redness, flaking, scaling associated with dandruff and seborrheic dermatitis.

Dosage and administration

for best results use at least twice a week or as directed by a doctor. for maximum control, use every time you shampoo. shake bottle before use. wet hair, massage onto scalp, rinse, repeat if desired.

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

Selenium sulfide 1%

Purpose

OTC - PURPOSE SECTION

Anti-dandruff, Anti-seborrheic dermatitis

Uses

INDICATIONS & USAGE SECTION

for the relief of itching, irritation, redness, flaking, scaling associated with dandruff and seborrheic dermatitis.

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
  • if condition worsens or does not improve after regular use of this product as directed, consult a doctor.

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

  • for best results use at least twice a week or as directed by a doctor.
  • for maximum control, use every time you shampoo.
  • shake bottle before use.
  • wet hair, massage onto scalp, rinse, repeat if desired.

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis Leaf Extract, Butylated Hydroxytoluene, Cetyl Alcohol, Cocamidopropyl Betaine, Disodium EDTA, D&C YELLOW 10, FD&C RED 40, Guar Hydroxypropyltrimonium Chloride, Panthenol, Phenoxyethanol, Propylene Glycol, Water, Sodium Laureth Sulfate, Stearyl Alcohol, Tocopheryl Acetate, Xanthan Gum.

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 - 177 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

treats

prosoriä

medicated
shampoo

selenium sulfide 1%

anti-dandruff
anti-seborrheic

6 FL OZ (177 mL)

Principal Display Panel - 177 mL Bottle Label
Principal Display Panel - 177 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
204642selenium sulfide 1 % Medicated ShampooPSN2
204642selenium sulfide 10 MG/ML Medicated ShampooSCD2
204642selenium sulfide 1 % Lotion ShampooSY2
204642selenium sulfide 1 % Medicated ShampooSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71573-121-12Prosoria Medicated177 mL in 1 BOTTLE, PLASTICLOTION/SHAMPOO1772

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71573-121PROSORIA MEDICATED (SELENIUM SULFIDE) LOTION/SHAMPOO [NUVOTHERA, INC.]2Current NDC, Legacy NDC, 1 package rows20240112_44eaaeb0-1400-4697-85d0-e8c2282c1cba.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71573-12171573-121-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 17 matching rows.

Name, UNII, Kind table
NameUNIIKind
Selenium SulfideZ69D9E381QACTIB
Water059QF0KO0RIACT
Cetyl alcohol936JST6JCNIACT
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE)B16G315W7AIACT
Aloe Vera LeafZY81Z83H0XIACT
Butylated Hydroxytoluene1P9D0Z171KIACT
Cocamidopropyl Betaine5OCF3O11KXIACT
D&C Yellow No. 1035SW5USQ3GIACT
Edetate Disodium Anhydrous8NLQ36F6MMIACT
FD&C Red No. 40WZB9127XOAIACT
PanthenolWV9CM0O67ZIACT
Propylene Glycol6DC9Q167V3IACT
Stearyl Alcohol2KR89I4H1YIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
Xanthan GumTTV12P4NEEIACT
Sodium Laureth-3 SulfateBPV390UAP0IACT
PhenoxyethanolHIE492ZZ3TIACT

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 MedicatedSELENIUM SULFIDENuvothera, Inc.44eaaeb0-1400-4697-85d0-e8c2282c1cba2024-01-11WarningsExact identifier
ndc (package): 71573-121-12
ndc (product): 71573-121
ndc11 (package): 71573012112
spl id: 6fec05aa-5d44-4667-98f7-c61ac09c6307
spl set id: 44eaaeb0-1400-4697-85d0-e8c2282c1cba

Reported adverse events (FAERS/openFDA)#

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