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Product NDC Code | 57337-053 | ||||
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Drug Name | Xtracare dandruff hair wash |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SHAMPOO | ||||
RxCUI drug identifier | 205023 | ||||
Application Number | M032 | ||||
Labeler Name | Rejoice International | ||||
Packages |
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Active ingredient
A list of the active, medicinal ingredients in the drug product.Active Ingredient Purpose Salicylic Acid 3% ........................... Anti-dandruff
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 shampoo, then rinse thoroughly 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 laureth sulfate, sodium lauryl sulfate, cocamidopropyl betaine, cocamide MEA, fragrance, polyquaternium-10, disodium EDTA, citric acid, benzyl alcohol, panthenol (pro-vitamin B5), triclosan, 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.*compare to active ingredients in Selsun Blue® naturals dandruff shampoo XtraCare® Dandruff Shampoo Salicylic Acid 3% Controls Flakes & Itch Intensive Moisturizers Enriched with Vitamin B5 11 Fl Oz (325 mL)
Purpose
Information about the drug product’s indications for use.Uses for relief of flaking and itching due to dandruff and sebhorreic dermatitis, and to help prevent their recurrence
Spl product data elements
Usually a list of ingredients in a drug product.XtraCare Dandruff Hair Wash Salicylic Acid WATER SODIUM LAURETH SULFATE SODIUM LAURYL SULFATE COCAMIDOPROPYL BETAINE COCO MONOETHANOLAMIDE POLYQUATERNIUM-10 (1000 MPA.S AT 2%) EDETATE DISODIUM CITRIC ACID MONOHYDRATE BENZYL ALCOHOL PANTHENOL TRICLOSAN FD&C BLUE NO. 1 SALICYLIC ACID SALICYLIC ACID
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 image
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.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other Information store at room temperature Questions/Comments? 1-855-345-5575 *This product is not manufactured or distributed by Chattem, Inc., owner of the registered trademark Selsun Blue® Naturals Dandruff Shampoo. DISTRIBUTED BY: REJOICE INTERNATIONAL INC NORTHVILLE, MI 48168, USA MADE IN CHINA
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 Ask a doctor before use if you have sebhorreic dermatitis in areas other than the scalp 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.
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