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| Product NDC Code | 71573-116 | ||||
|---|---|---|---|---|---|
| Drug Name | Prosoria scalp |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | LOTION/SHAMPOO | ||||
| RxCUI drug identifier | 244525 | ||||
| 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, 1.8%
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 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.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients 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.
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 symptoms of psoriasis and/or seborrheic dermatitis including: scaling flaking itching redness irritation
Purpose
Information about the drug product’s indications for use.Purpose Antipsoriasis, antiseborrheic
Spl product data elements
Usually a list of ingredients in a drug product.Prosoria Scalp Salicylic Acid Salicylic Acid Salicylic Acid Water Diethylene Glycol Monoethyl Ether AMMONIUM ACRYLOYLDIMETHYLTAURATE, DIMETHYLACRYLAMIDE, LAURYL METHACRYLATE AND LAURETH-4 METHACRYLATE COPOLYMER, TRIMETHYLOLPROPANE TRIACRYLATE CROSSLINKED (45000 MPA.S) Tetrahydrodiferuloylmethane TURMERIC Petrolatum Oleth-3 Phosphate Edetate Disodium Anhydrous Sodium Hydroxide Butylene Glycol Nigella Sativa Seed Oil Citric Acid Monohydrate .ALPHA.-TOCOPHEROL ACETATE POLYISOBUTYLENE (1300 MW) BETADEX Phenoxyethanol HYDROXYETHYL ACRYLATE/SODIUM ACRYLOYLDIMETHYL TAURATE COPOLYMER (100000 MPA.S AT 1.5%) Undecylenoyl Glycine Capryloyl Glycine PEG-7 Trimethylolpropane Coconut Ether Off White Light Yellow
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 - 74 mL Bottle Label treats prosoriä scalp lotion 1.8% salicylic acid anti-psoriasis anti-seborrheic 2.5 FL OZ (74mL) PRINCIPAL DISPLAY PANEL - 74 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, Texas 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.
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. 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