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Product NDC Code | 50157-125 | ||||||
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Drug Name | Pyrithione zinc |
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Type | Generic | ||||||
Active Ingredients |
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Route | TOPICAL | ||||||
Dosage Form | SHAMPOO | ||||||
RxCUI drug identifier | 1052932 | ||||||
Application Number | M032 | ||||||
Labeler Name | BRANDS INTERNATIONAL | ||||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Pyrithione Zinc 0.3%
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.For maximum dandruff control, use every time you shampoo. Wet hair, massage unto scalp, rinse, and repeat if desired. For best results use at least twice a week or as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Water, Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Glycol Distearate, Aloe vera Leaf Extract, Parfum, Vitamin E, Methylchloroisothiazolinone,Methylisothiazolinone, FD&C Blue#1 ,FD&C Red#33.
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.Helps prevent recurrence of flaking and itching associated with dandruff.
Purpose
Information about the drug product’s indications for use.Anti-dandruff
Spl product data elements
Usually a list of ingredients in a drug product.PYRITHIONE ZINC PYRITHIONE ZINC WATER SODIUM CHLORIDE GLYCOL DISTEARATE EDETATE SODIUM ALOE VERA LEAF D&C RED NO. 33 BASIC BLUE 1 .ALPHA.-TOCOPHEROL COCAMIDOPROPYL BETAINE METHYLISOTHIAZOLINONE SODIUM LAURYL SULFATE METHYLCHLOROISOTHIAZOLINONE PYRITHIONE ZINC PYRITHIONE ZINC
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.1
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 children’s reach.
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.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.Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water.
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.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