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Product NDC Code | 52000-415 | ||||
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Drug Name | Pyrithione zinc 0.5 2in1 dandruff conditioner |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SHAMPOO | ||||
RxCUI drug identifier | 1043014 | ||||
Application Number | M032 | ||||
Labeler Name | Universal Distribution Center LLC | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient: Pyrithione zinc 0.5% W/V
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: 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, Cocamide Mea, Sodium Lauryl Sulfate, Cocamidopropyl Betaine, Sodium Chloride, Coconut Milk, Acrylated Co Polymer, Glycerin, Fragrance, Citric Acid, Disodium Edta, Aloe Barbadensis Leaf Juice, Methylchloroisothiazolinone, Methylisothiazolinone, Guar Hydroxypropyltrimonium Chloride, Glycol Distearate, Menthol, Polyquaternium-10, Fd & C Blue No.1
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: 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.Pyrithione Zinc 0.5 2in1 Dandruff Conditioner Pyrithione Zinc PYRITHIONE ZINC PYRITHIONE ZINC WATER COCO MONOETHANOLAMIDE SODIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE SODIUM CHLORIDE COCONUT BUTYL ACRYLATE/METHYL METHACRYLATE/METHACRYLIC ACID COPOLYMER (18000 MW) GLYCERIN CITRIC ACID MONOHYDRATE EDETATE DISODIUM ALOE VERA LEAF METHYLCHLOROISOTHIAZOLINONE METHYLISOTHIAZOLINONE GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE GLYCOL DISTEARATE MENTHOL, UNSPECIFIED FORM POLYQUATERNIUM-10 (400 MPA.S AT 2%) FD&C BLUE NO. 1
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.Packaging ShampooConditioner 415
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
U COCONUT Shampoo Conditioner 2IN1 Helps keep hair strong and smooth Distributed by: Universal Distribution Center LLC 96 Distribution Boulevard, Edison, NJ 08817 www.universaldc.com Made in India
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.
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 Avoid contact with eyes. If contact occurs, rinse eyes thoroughly with water. Stop use and ask a doctor if Condition worsens or does not improve after regular use of this product as directed. If swallowed, get medical help or contact a Poison Control Center right away. Keep out of reach of children.
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