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| Product NDC Code | 63766-300 | ||||||
|---|---|---|---|---|---|---|---|
| Drug Name | Affirmcare scalp therapy hydrating 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 Zinc Pyrithione 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 For best results, use at least twice a week, or as directed by a doctor. Shake well before use. Apply by massaging onto wet hair and scalp. Rinse and repeat. Follow with Scalp Therapy Hydrating Anti-Dandruff Conditioner.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive Ingredient Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Disodium Laureth Sulfosuccinate, Betaine, Cocamidopropyl Betaine, Cocamide MIPA, Sodium Cocoyl Isethionate, Cetyl Alcohol, Melia Azadirachta Seed Oil, Origanum Vulgare Leaf Extract, Linum Usitatissimum (Linseed) Seed Extract, Camellia Sinensis Leaf Extract, Menthol, Keratin, Hydrolyzed Keratin, Glycol Stearate, Glycerin, Piroctone Olamine, Phenoxyethanol, Caprylyl Glycol, Caprylic Acid, Fragrance/Parfum, Tetrasodium EDTA, Ceteareth-60 Myristyl Glycol, Quaternium-80, Polyquaternium-10, Propanediol, Benzyl Benzoate, Limonene, Hexyl Cinnamal.
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 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.AffirmCare Scalp Therapy Hydrating Anti-Dandruff PYRITHIONE ZINC LIMONENE, (+)- BENZYL BENZOATE WATER SODIUM COCOYL ISETHIONATE LINSEED OIL GLYCOL STEARATE POLYQUATERNIUM-10 (125 MPA.S AT 2%) PIROCTONE OLAMINE PIROCTONE AZADIRACHTA INDICA SEED OIL ALOE VERA LEAF PROPANEDIOL OREGANO GREEN TEA LEAF COCAMIDOPROPYL BETAINE BETAINE DISODIUM LAURETH SULFOSUCCINATE COCO MONOISOPROPANOLAMIDE CETYL ALCOHOL CAPRYLYL GLYCOL MENTHOL CETEARETH-60 MYRISTYL GLYCOL EDETATE SODIUM EDETIC ACID GLYCERIN PHENOXYETHANOL PYRITHIONE ZINC PYRITHIONE ZINC .ALPHA.-HEXYLCINNAMALDEHYDE CAPRYLIC ACID HYDROLYZED SHEEP WOOL KERATIN (2000 MW) AMINO ACIDS, HAIR KERATIN 2-(CYCLOHEXYLAMINO)ETHANESULFONIC 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.AffirmCare Scalp Therapy Hydrating Anti-Dandruff Shampoo (8 oz & 32 oz) Product NDC# 63766-300 Label
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 that 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 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? 1-800-332-8566
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 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.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