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Pyrithione zinc - Medication Information

Product NDC Code 50157-125
Drug Name

Pyrithione zinc

Type Generic
Active Ingredients
Pyrithione zinc .3 g/100ml
Route TOPICAL
Dosage Form SHAMPOO
RxCUI drug identifier 1052932
Application Number M032
Labeler Name BRANDS INTERNATIONAL
Packages
Package NDC Code Description
50157-125-10 295 ml in 1 bottle (50157-125-10)
50157-125-35 355 ml in 1 bottle (50157-125-35)
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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