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| Product NDC Code | 70000-0550 | ||||
|---|---|---|---|---|---|
| Drug Name | Leader therapeutic dandruff anti-dandruff, anti-seborrheic dematitis and anti-psoriasis |
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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 | Cardinal Health | ||||
| 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 Salicylic Acid 3.0%
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 ⬥ for best results use at least twice a week or as directed by a doctor ⬥ wet hair thoroughly ⬥ massage shampoo into scalp ⬥ lather, leave on hair and scalp for several minutes ⬥ rinse and repeat.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients water, sodium C14-16 olefin sulfonate, sodium laureth sulfate, cocamidopropyl betaine, cocamide MEA, PEG-150 distearate, polyquaternium-10, propylene glycol, sodium citrate, sodium hydroxide.
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 control the symptoms of ⬥ dandruff ⬥ seborrheic dermatitis ⬥ psoriasis
Purpose
Information about the drug product’s indications for use.Purpose Anti-dandruff, anti-seborrheic dermatitis and anti-psoriasis
Spl product data elements
Usually a list of ingredients in a drug product.Leader Therapeutic Dandruff Anti-Dandruff, anti-seborrheic dematitis and anti-psoriasis Salicylic Acid Salicylic Acid Salicylic Acid Water SODIUM LAURETH-3 SULFATE Cocamidopropyl Betaine COCO MONOETHANOLAMIDE Sodium C14-16 Olefin Sulfonate POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600000 MW) Propylene Glycol PEG-150 Distearate POLYQUATERNIUM-10 (30000 MPA.S AT 2%) SODIUM CITRATE, UNSPECIFIED FORM Sodium Hydroxide
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 - 133 mL Bottle Label LEADER ™ NDC 70000-0550-1 Therapeutic Dandruff Shampoo Salicylic Acid, 3% Anti-Dandruff Anti-Seborrheic Dermatitis Anti-Psoriasis Controls the Symptoms of Psoriasis, Seborrheic Dermatitis & Dandruff Clears & Helps Prevent Scalp Buildup Fragrance-Free Dye-Free Preservative-Free COMPARE TO NEUTROGENA ® T/SAL ® active ingredient* 100% Money Back Guarantee 4.5 FL OZ (133 mL) 05-3791B Principal Display Panel - 133 mL Bottle Label
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
DISTRIBUTED BY CARDINAL HEALTH DUBLIN, OHIO 43017
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.Ask a doctor before use if you have a condition which covers a large area of the body.
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 (1-800-222-1222) 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? 1-866-567-8600
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.
Storage and handling
Information about safe storage and handling of the drug product.Other information ⬥ store at room temperature ⬥ store away from direct sunlight.
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 a condition which covers a large area of the body. 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 (1-800-222-1222) right away.
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