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Product NDC Code | 50718-0035 | ||||
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Drug Name | Control dandruff- free beard wash |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SHAMPOO | ||||
RxCUI drug identifier | 209884 | ||||
Application Number | M032 | ||||
Labeler Name | Kamedis Inc | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredient Pyrithione Zinc 1.0%
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 adults and children 3 years of age and older: apply to wet beard or hair gently massage into beard, hair and scalp and leave for 2-3 minutes before thoroughly rinsing. rinse and repeat if desired for best results use at least twice a week or as directed by your doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients ammonium laureth sulfate, water, ammonium lauryl sulfate, cocamidopropyl betaine, sodium lauroyl sarcosinate, soapberry (Sapindus mukurossi) fruit extract, salicylic acid, salt (sodium chloride), polyquaternium-10, sodium benzoate, triethanolamine, fragrance
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 eliminate flaking, itching and scaling associated with dandruff and seborrheic dermatitis
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.CONTROL Dandruff- Free Beard Wash PYRITHIONE ZINC PYRITHIONE ZINC PYRITHIONE ZINC AMMONIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE SALICYLIC ACID SODIUM CHLORIDE SAPINDUS MUKOROSSI FRUIT SODIUM BENZOATE SODIUM LAUROYL SARCOSINATE WATER AMMONIUM LAURETH-2 SULFATE POLYQUATERNIUM-10 (10000 MPA.S AT 2%) TROLAMINE
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.PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton Kamedis ® Skin Restoring Solutions BOTANIPLEX TECHNOLOGY CONTROL Dandruff Free Beard Wash PYRITHIONE ZINC 1% Prevents and fights beard flaking. Relieves irritation redness and itchiness associated with dandruff. Leaves the beard shiny and smooth DERMATOLOGIST RECOMMENDED Free from Parabens, Steroids, Dyes, Sodium Lauryl Sulfate, Tar 200 mL 6.7 fl oz PRINCIPAL DISPLAY PANEL - 200 mL Bottle Carton
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
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. If condition covers a large area of the body, consult your doctor before using this product.
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 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.When using this product avoid contact with the 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.Warnings For external use only When using this product avoid contact with the 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 Keep out of reach of children If swallowed, get medical help or contact a Poison Control Center right away. If condition covers a large area of the body, consult your doctor before using this product.
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