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| Product NDC Code | 51326-203 | ||||
|---|---|---|---|---|---|
| Drug Name | Zolidyne |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SHAMPOO | ||||
| RxCUI drug identifier | 244458 | ||||
| Application Number | M032 | ||||
| Labeler Name | Topiderm, 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 Zinc Pyrithione, 2%
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 Massage into wet scalp, lather well and rinse, leaving lather on scalp for 3-5 minutes For best results, use at least twice a week or as directed by your doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients Ammonium Lauryl Sulfate, Citric Acid, Cocamidopropyl Betaine, Ethylene Glycol Distearate, FD&C Blue #1, Fragrance, Glycerin, Hydroxypropyl Methylcellulose, Lauramide MIPA, Methylchloroisothiazolinone, Methylisothiazolinone, Sodium Laureth Sulfate, 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 A gentle, specially formulated shampoo for the control of flaking and itching associated with dandruff or seborrheic dermatitis.
Purpose
Information about the drug product’s indications for use.Purpose Antidandruff, Seborrheic Dermatitis
Spl product data elements
Usually a list of ingredients in a drug product.Zolidyne Pyrithione Zinc PYRITHIONE ZINC PYRITHIONE ZINC AMMONIUM LAURYL SULFATE CITRIC ACID MONOHYDRATE COCAMIDOPROPYL BETAINE GLYCOL DISTEARATE FD&C BLUE NO. 1 GLYCERIN HYPROMELLOSE, UNSPECIFIED LAURIC ISOPROPANOLAMIDE METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE SODIUM LAURETH-3 SULFATE WATER
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 - 200 ml Tube Label DERMA TOPIX zolidyne shampoo Zinc Pyrithione, 2% Net 6.7 fl. oz. (200 ml.) Topix Pharmaceuticals, Inc. N. Amityville, NY 11701 PRINCIPAL DISPLAY PANEL - 200 ml Tube 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
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. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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 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 If condition covers a large area of the body, consult your doctor before using this product Keep out of reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.
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