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NDC 71573-0117-03 Prosoria Psoriasis Treatment Details

Prosoria Psoriasis Treatment

Prosoria Psoriasis Treatment is a KIT in the HUMAN OTC DRUG category. It is labeled and distributed by Nuvothera, Inc.. The primary component is .

MedlinePlus Drug Summary

Topical salicylic acid is used to help clear and prevent pimples and skin blemishes in people who have acne. Topical salicylic acid is also used to treat skin conditions that involve scaling or overgrowth of skin cells such as psoriasis (a skin disease in which red, scaly patches form on some areas of the body), ichthyoses (inborn conditions that cause skin dryness and scaling), dandruff, corns, calluses, and warts on the hands or feet. Topical salicylic acid should not be used to treat genital warts, warts on the face, warts with hair growing from them, warts in the nose or mouth, moles, or birthmarks. Salicylic acid is in a class of medications called keratolytic agents. Topical salicylic acid treats acne by reducing swelling and redness and unplugging blocked skin pores to allow pimples to shrink. It treats other skin conditions by softening and loosening dry, scaly, or thickened skin so that it falls off or can be removed easily.

Related Packages: 71573-0117-03
Last Updated: 12/01/2022
MedLinePlus Full Drug Details: Salicylic Acid Topical

Product Information

NDC	71573-0117
Product ID	71573-117_8763d64b-b32d-48b2-87e1-d21411eb3bf9
Associated GPIs
GCN Sequence Number	n/a
GCN Sequence Number Description	n/a
HIC3	n/a
HIC3 Description	n/a
GCN	n/a
HICL Sequence Number	n/a
HICL Sequence Number Description	n/a
Brand/Generic	n/a
Proprietary Name	Prosoria Psoriasis Treatment
Proprietary Name Suffix	n/a
Non-Proprietary Name	Salicylic Acid
Product Type	HUMAN OTC DRUG
Dosage Form	KIT
Route	n/a
Active Ingredient Strength	n/a
Active Ingredient Units	n/a
Substance Name	n/a
Labeler Name	Nuvothera, Inc.
Pharmaceutical Class	n/a
DEA Schedule	n/a
Marketing Category	OTC MONOGRAPH FINAL
Application Number	part358H
Listing Certified Through	2023-12-31

Package

Package Images

NDC 71573-0117-03 (71573011703)

Pricing Information	N/A
NDC Package Code	71573-117-03
Billing NDC	71573011703
Package	1 KIT in 1 CARTON (71573-117-03) * 59 mL in 1 BOTTLE, PLASTIC (71573-102-01) * 60 g in 1 TUBE
Marketing Start Date	2022-02-18
NDC Exclude Flag	N

Standard Product Labeling (SPL)/Prescribing Information SPL 378311aa-95f7-4c69-bc00-e688468262bd Details

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

Salicylic acid, 3%

Purpose

Antipsoriasis

Uses

relieves and helps prevent recurrence of psoriasis symptoms 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 and/or if condition covers a large area of the body.

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

Directions

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

Other information

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

Inactive ingredients

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

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, TX

PRINCIPAL DISPLAY PANEL - Kit Carton

DERMATOLOGIST TESTED

prosoriä

PSORIASIS

treatment system

maximum strength

Salicylic Acid 3% Gel

plus soothing botanicals and vitamins

once daily

2

STEP KIT

once daily

NATIONAL

PSORIASIS

FOUNDATION

RECOGNIZED

Once Daily
Relieves:

itching,

redness &

irritated

skin
Rapidly

removes

scaling &

flaking
Softens &

moisturizes

Antioxidant Rich Formula

turmeric root, curcumin shea butter, vitamin E

TREATMENT GEL

2 FL OZ (59mL)

MOISTURIZING OINTMENT

NET WT 2OZ (60g)

INGREDIENTS AND APPEARANCE

PROSORIA PSORIASIS TREATMENT

salicylic acid kit

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:71573-117

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71573-117-03	1 in 1 CARTON	02/18/2022

Part #	Package Quantity	Total Product Quantity
Quantity of Parts
Part 1	1 BOTTLE, PLASTIC	59 mL
Part 2	1 TUBE	60 g

Part 1 of 2
PROSORIA PSORIASIS TREATMENT salicylic acid gel

Product Information
Item Code (Source)	NDC:71573-102
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	1.77 g in 59 mL

Ingredient Name	Strength
Inactive Ingredients
Water (UNII: 059QF0KO0R)
Diethylene Glycol Monoethyl Ether (UNII: A1A1I8X02B)
Tetrahydrodiferuloylmethane (UNII: 00U0645U03)
Turmeric (UNII: 856YO1Z64F)
Gamma Cyclodextrin (UNII: KZJ0BYZ5VA)
Oleth-3 Phosphate (UNII: 8Q0Z18J1VL)
Edetate Disodium Anhydrous (UNII: 8NLQ36F6MM)
Sodium Hydroxide (UNII: 55X04QC32I)
Potassium Hydroxide (UNII: WZH3C48M4T)
Potassium Sorbate (UNII: 1VPU26JZZ4)
Citric Acid Monohydrate (UNII: 2968PHW8QP)

Product Characteristics
Color	WHITE (Off White Beige)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:71573-102-01	59 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part358H	11/22/2017

Part 2 of 2
EXFOLIATING AND MOISTURIZING other skin care preparations ointment

Product Information
Route of Administration	TOPICAL

Ingredient Kind	Ingredient Name	Quantity
Other Ingredients
INGR	Petrolatum (UNII: 4T6H12BN9U)
INGR	SHEA BUTTER (UNII: K49155WL9Y)
INGR	ALKYL (C12-15) BENZOATE (UNII: A9EJ3J61HQ)
INGR	Salicylic Acid (UNII: O414PZ4LPZ)
INGR	Paraffin (UNII: I9O0E3H2ZE)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1		60 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
COSMETIC

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part358H	02/18/2022

Labeler - Nuvothera, Inc. (080499864)

Name	Address	ID/FEI	Business Operations
Establishment
Swiss-American CDMO		080170933	MANUFACTURE(71573-117)

Name	Address	ID/FEI	Business Operations
Establishment
Global Packaging Systems		964987890	LABEL(71573-117) , PACK(71573-117)

Revised: 3/2022

Document Id: 8763d64b-b32d-48b2-87e1-d21411eb3bf9

Set id: 378311aa-95f7-4c69-bc00-e688468262bd

Version: 2

Effective Time: 20220308

Search by Drug Name or NDC

NDC 71573-0117-03 Prosoria Psoriasis Treatment Details

Prosoria Psoriasis Treatment

MedlinePlus Drug Summary

Product Information

Package

Package Images

NDC 71573-0117-03 (71573011703)

Contents

Standard Product Labeling (SPL)/Prescribing Information SPL 378311aa-95f7-4c69-bc00-e688468262bd Details

SPL UNCLASSIFIED SECTION

Active ingredient

Purpose

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions?

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL - Kit Carton

INGREDIENTS AND APPEARANCE

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