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| Product NDC Code | 71573-102 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Prosoria psoriasis treatment |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | GEL | ||||||
| RxCUI drug identifier | 283602 | ||||||
| Application Number | M032 | ||||||
| Labeler Name | Nuvothera, Inc. | ||||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Salicylic acid, 3%
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.Directions apply to affected areas once daily or as directed by a doctor use in conjunction with the Prosoria Daily Psoriasis Treatment System.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.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.
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses relieves and helps prevent recurrence of psoriasis symptoms including: scaling flaking itching redness irritation
Purpose
Information about the drug product’s indications for use.Purpose Antipsoriasis
Spl product data elements
Usually a list of ingredients in a drug product.Prosoria Psoriasis Treatment Salicylic Acid Salicylic Acid Salicylic Acid Water Diethylene Glycol Monoethyl Ether Tetrahydrodiferuloylmethane TURMERIC GAMMA CYCLODEXTRIN Oleth-3 Phosphate Edetate Disodium Anhydrous Sodium Hydroxide Potassium Hydroxide Potassium Sorbate Citric Acid Monohydrate Off White Beige
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label prosoria MAXIMUM STRENGTH treats psoriasis treatment gel 3% salicylic acid 2 FL OZ (59mL) PRINCIPAL DISPLAY PANEL - 59 mL Bottle Label
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Distributed by Nuvothera, Inc. Fort Worth, TX 76104
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? Visit www.prosoria.com or call toll-free 1-833-776-7483 Mon - Fri, 8am - 5pm CT.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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.
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.When using this product avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
Storage and handling
Information about safe storage and handling of the drug product.Other information store at room temperature 59-77°F (15-25°C).
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API