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Dandruff - Medication Information

Product NDC Code 74553-003
Drug Name

Dandruff

Type Brand
Active Ingredients
Pyrithione zinc 2 g/100ml
Route TOPICAL
Dosage Form SHAMPOO
RxCUI drug identifier 244458
Application Number part358H
Labeler Name Xtreme Tools International, Inc
Packages
Package NDC Code Description
74553-003-01 473 ml in 1 bottle, plastic (74553-003-01)
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Active ingredient

A list of the active, medicinal ingredients in the drug product.
Active Ingredient Pyrithione zinc 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 shake well 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, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Cocamide MEA, Glycol Distearate, Polysorbate 20,PPG-10 Cetyl Ether, PEG-8, Polyquaternium-10, Acrylates, Vinyl Neodecanoate, Crosspolymer, Hydrolyzed Wheat Protein, Ricinus Communis (Castor) Seed Oil, Hydrolyzed Keratin, Chitosan Succinamide, Argania Spinosa (Argan) Kemel Oil, Olea Europaea (Olive) Oil, Sodium Benzoate, Pottassium Sorbate, Fragrance, Citric Acid, CI 42090

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 itching and flaking 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 ARGAN OIL OLIVE OIL CITRIC ACID MONOHYDRATE SODIUM C14-16 OLEFIN SULFONATE COCAMIDOPROPYL BETAINE GLYCOL DISTEARATE POLYETHYLENE GLYCOL 400 DIMETHICONE/VINYL DIMETHICONE CROSSPOLYMER (SOFT PARTICLE) WATER POLYSORBATE 20 COCO MONOETHANOLAMIDE PPG-10 CETYL ETHER HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) COCODIMONIUM HYDROXYPROPYL HYDROLYZED KERATIN (1000 MW) PYRITHIONE ZINC PYRITHIONE ZINC POLYQUATERNIUM-10 (125 MPA.S AT 2%) ACRYLATES/VINYL ISODECANOATE CROSSPOLYMER (10000 MPA.S NEUTRALIZED AT 0.5%) SODIUM BENZOATE POTASSIUM SORBATE FD&C BLUE NO. 1 VINYL NEODECANOATE CASTOR OIL CHITOSAN SUCCINAMIDE (1300 MPA.S)

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.
PACKAGE LABEL 473 mL in Bottle; NDC 74553-003-01 SHAMPOO

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 Poison Control Center right away.

Questions

A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.
Questions or comments? Call 1-305-622-7474, Monday through Friday 9:00 AM to 5:00 PM

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 of this product.

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.
When using this 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.
Warning 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