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| Product NDC Code | 63766-002 | ||||||||
|---|---|---|---|---|---|---|---|---|---|
| Drug Name | Keracare dry and itchy scalp anti-dandruff |
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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 | Avlon Industries, Inc. | ||||||||
| 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 Pyrithione Zinc 1%
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 Apply to wet hair and gently lather with fingertips. Rinse and repeat. Leave on 5 minutes. Shampoo with KeraCare® Hydrating Detangling Shampoo for a final sudsing. For best results, follow with KeraCare® Dry & Itchy Scalp Anti-Dandruff Moisturizing Conditioner.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredients Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Disodium Laureth Sulfosuccinate, Cocamidopropyl Betaine, Cocamide MIPA, Polysorbate 20, Sodium Cocoyl Isethionate, Cetyl Alcohol, Glycerin, Menthol, Piroctone Olamine, Pyrus Malus (Apple) Fruit Extract, Citrus Limon (Lemon) Peel Extract , Camellia Sinensis Leaf Extract, Fragrance/Parfum, Quaternium-80, Propanediol, Polyquaternium-10, Caprylyl Glycol, Phenoxyethanol, Tetrasodium EDTA, Citric Acid, Benzyl Salicylate, Hexyl Cinnamal, Linalool, Blue 1 (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 for the relief of scalp flaking, itching and irritation associated with dandruff and seborrheic dermatitis.
Purpose
Information about the drug product’s indications for use.Purpose Anti-Dandruff, Anti-Seborrheic Dermatitis
Spl product data elements
Usually a list of ingredients in a drug product.KeraCare Dry and Itchy Scalp Anti-Dandruff Pyrithione Zinc LINALOOL, (+/-)- WATER ALOE VERA LEAF DISODIUM LAURETH SULFOSUCCINATE COCAMIDOPROPYL BETAINE GLYCERIN POLYSORBATE 20 SODIUM COCOYL ISETHIONATE CAPRYLYL GLYCOL COCO MONOISOPROPANOLAMIDE CETYL ALCOHOL APPLE PROPANEDIOL PHENOXYETHANOL EDETATE SODIUM EDETIC ACID .ALPHA.-HEXYLCINNAMALDEHYDE MENTHOL PIROCTONE OLAMINE PIROCTONE LEMON PEEL GREEN TEA LEAF FD&C BLUE NO. 1 CITRIC ACID MONOHYDRATE BENZYL SALICYLATE SALICYLIC ACID POLYQUATERNIUM-10 (30000 MPA.S AT 2%) 2-(CYCLOHEXYLAMINO)ETHANESULFONIC ACID PYRITHIONE ZINC PYRITHIONE ZINC
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.KeraCare Dry and Itchy Scalp Anti-Dandruff Moisturizing Shampoo Product NDC 63766-002 Label
Recent major changes
A list of the section(s) that contain substantive changes that have been approved by FDA in the product labeling. The headings and subheadings, if appropriate, affected by the change are listed together with each section’s identifying number and the month and year on which the change was incorporated in the labeling.Dosage and Administration Section Section 9 10/2019
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 ■ seborrheic dermatitis that covers large areas of your 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 right away.
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 with regular use. -----------------------------------------------------------------------------------------------------
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 getting into eyes. In event of contact, rinse eyes thoroughly with water. ■ Use caution in exposing skin to sunlight after applying this product. It may increase your tendency to sunburn for up to 24 hours after application. -----------------------------------------------------------------------------------------------------
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 -----------------------------------------------------------------------------------------------------
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