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| Product NDC Code | 80801-103 | ||||
|---|---|---|---|---|---|
| Drug Name | Dandruff |
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| Type | Brand | ||||
| Active Ingredients |
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| Route | TOPICAL | ||||
| Dosage Form | SHAMPOO | ||||
| RxCUI drug identifier | 1052932 | ||||
| Application Number | M032 | ||||
| Labeler Name | Primal Elements | ||||
| 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 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.Directions • shake well • for maximum dandruff control, use every time you shampoo • wet hair, massage onto scalp, rinse, 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.Inactive ingredients Water (Aqua), Sodium Laureth Sulfate, Cocamidopropyl Betaine, Sodium Lauryl Sulfate, Cocamide MEA, Styrene/Acrylates Copolymer, Guar Hydroxypropyltrimonium Chloride, Sodium Citrate, Fragrance, Sodium Chloride, Dimethicone, Methylisothiazolinone, Iodopropynyl Butylcarbamate
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.Use helps prevent recurrence of flaking and itching associated with dandruff.
Purpose
Information about the drug product’s indications for use.Purpose Anti-dandruff
Spl product data elements
Usually a list of ingredients in a drug product.DANDRUFF pyrithione zinc SODIUM CITRATE SODIUM CHLORIDE METHYLISOTHIAZOLINONE DIMETHICONE IODOPROPYNYL BUTYLCARBAMATE FD&C BLUE NO. 1 WATER SODIUM LAURYL SULFATE PYRITHIONE ZINC PYRITHIONE ZINC COCAMIDOPROPYL BETAINE SODIUM LAURETH SULFATE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) STYRENE/ACRYLAMIDE COPOLYMER (500000 MW)
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.label
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 Posion Control Center right away.
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 ask a doctor if condition worsens or does not improve after regular use as directed.
Storage and handling
Information about safe storage and handling of the drug product.Other information Store at room temperature.
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 do not get into eyes. If contact occurs, rinse eyes thoroughly with water.
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