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| Product NDC Code | 55505-202 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Nizoral psoriasis |
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| Type | Brand | ||||||
| Active Ingredients |
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| Route | TOPICAL | ||||||
| Dosage Form | SHAMPOO | ||||||
| RxCUI drug identifier | 205023, 2467167 |
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| Application Number | M032 | ||||||
| Labeler Name | Kramer Laboratories | ||||||
| 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 Purpose Salicylic Acid 3% Psoriasis and Seborrheic Dermatitis
| Salicylic Acid 3% | Psoriasis and Seborrheic Dermatitis |
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 for best results use at least twice a week or as directed by a doctor wet hair thoroughly massage liberal amount of product into scalp leave lather on for several minutes rinse thoroughly and repeat if needed
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Ascorbic Acid, Cocamidopropyl Betaine, DL Panthenol USP Powder, Green Tea Extract, Linolemidopropyl PG-Dimonium Chloride Phosphate, PEG-120 Methyl Glucose Dioleate, Polyquaternium-7, Propylene Glycol, Puried Water, Sodium C-14-16 Olefin Sulfonate, Tea Tree Oil, Trolamine, Vitamin E Acetate
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 scalp: irritation itching redness flaking scaling due to psoriasis and seborrheic dermatitis
Purpose
Information about the drug product’s indications for use.Active ingredient Purpose Salicylic Acid 3% Psoriasis and Seborrheic Dermatitis
| Salicylic Acid 3% | Psoriasis and Seborrheic Dermatitis |
Spl product data elements
Usually a list of ingredients in a drug product.Nizoral Psoriasis Salicylic Acid Salicylic Acid Salicylic Acid Water Sodium C14-16 Olefin Sulfonate Cocamidopropyl Betaine Peg-120 Methyl Glucose Dioleate Polyquaternium-7 (70/30 Acrylamide/Dadmac; 1600000 Mw) Trolamine Panthenol .Alpha.-Tocopherol Acetate Tea Tree Oil Green Tea Leaf Ascorbic Acid 11 oz front label 11 oz back label 11 oz carton
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 Nizoral ® Psoriasis SALICYLIC ACID 3% SHAMPOO & CONDITIONER Scalp Psoriasis Shampoo & Conditioner with Tea Tree Oil CONTROLS Redness, Flaking and Scaling RELIEVES Itching and Scalp Irritation FAST-ACTING Starts Working from First Use Sulfate, Dye and Alcohol-Free 11 fl oz (325mL) Specially formulated with: ✓ Tea Tree Oil ✓ Green Tea ✓ Vitamin E ✓ Vitamin B5 ✓ Vitamin C Free of: X Sulfates X Dyes X Alcohol X Artificial Fragrances X Preservatives X Parabens What is Scalp Psoriasis? Scalp psoriasis is a chronic inflammatory condition that comes and goes. Symptoms may include irritation, itching, redness, and flaking. How does Nizoral Psoriasis Shampoo & Conditioner work? Nizoral contains maximum strength medicine to relieve and help prevent scalp psoriasis symptoms while leaving hair clean and conditioned. The special formula contains tea tree oil, green tea and vitamins E, C and B5 - plus it's free of artificial fragrances, preservatives, and dyes that may irritate skin. Read all information on this packaging and keep for future reference. Before use, read all label information. If you have a drug reaction, contact a doctor and report it by calling: 1.800.824.4894 Distributed by: Kramer Laboratories, Inc. Bridgewater, NJ 08807 USA © 2022 KRAMER LABORATORIES, INC. K1222 Nizoral ® Psoriasis SALICYLIC ACID 3% SHAMPOO & CONDITIONER Scalp Psoriasis Shampoo & Conditioner with Tea Tree Oil CONTROLS Redness, Flaking and Scaling RELIEVES Itching and Scalp Irritation FAST-ACTING Starts Working from First Use Sulfate, Dye and Alcohol-Free 11 fl oz (325mL)
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have psoriasis that covers a large area of the body if you are allergic to ingredients in this product
Stop use and ask a doctor if condition worsens or does not improve after regular use as directed
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 (1-800-222-1222) 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 or comments? Call 800-824-4894
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 the eyes thoroughly with water
Storage and handling
Information about safe storage and handling of the drug product.Other information store between 20° – 25°C (68° – 77°F)
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
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