PROSORIA MEDICATED- selenium sulfide lotion/shampoo

Prosoria Medicated by

Drug Labeling and Warnings

Prosoria Medicated by is a Otc medication manufactured, distributed, or labeled by Nuvothera, Inc., Quality CDMO. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Selenium sulfide 1%

Purpose

Anti-dandruff, Anti-seborrheic dermatitis

Uses

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

Warnings

For external use only

When using this product

• 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.

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

Directions

• 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

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

Inactive ingredients

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?

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

treats

prosoriä

medicated
shampoo

selenium sulfide 1%

anti-dandruff
anti-seborrheic

6 FL OZ (177 mL)

INGREDIENTS AND APPEARANCE

PROSORIA MEDICATED 
selenium sulfide lotion/shampoo

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 71573-121
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Selenium Sulfide (UNII: Z69D9E381Q) (Selenium Sulfide - UNII:Z69D9E381Q)	Selenium Sulfide	1.77 g  in 177 mL

Inactive Ingredients
Ingredient Name	Strength
Water (UNII: 059QF0KO0R)
Cetyl alcohol (UNII: 936JST6JCN)
GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) (UNII: B16G315W7A)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)
Cocamidopropyl Betaine (UNII: 5OCF3O11KX)
D&C Yellow No. 10 (UNII: 35SW5USQ3G)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
FD&C Red No. 40 (UNII: WZB9127XOA)
Panthenol (UNII: WV9CM0O67Z)
Propylene Glycol (UNII: 6DC9Q167V3)
Stearyl Alcohol (UNII: 2KR89I4H1Y)
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
Xanthan Gum (UNII: TTV12P4NEE)
Sodium Laureth-3 Sulfate (UNII: BPV390UAP0)
Phenoxyethanol (UNII: HIE492ZZ3T)

Product Characteristics
Color	ORANGE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71573-121-12	177 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
Quality CDMO		117658386	MANUFACTURE(71573-121)