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Affirmcare scalp therapy hydrating anti-dandruff conditioner - Medication Information

Product NDC Code 63766-301
Drug Name

Affirmcare scalp therapy hydrating anti-dandruff conditioner

Type Brand
Active Ingredients
Pyrithione zinc 10 mg/ml
Route TOPICAL
Dosage Form LOTION
RxCUI drug identifier 209884
Application Number M032
Labeler Name Avlon Industries, Inc.
Packages
Package NDC Code Description
63766-301-02 950 ml in 1 bottle (63766-301-02)
63766-301-72 240 ml in 1 tube (63766-301-72)
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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 after rinsing Scalp Therapy Hydrating Anti-Dandruff Shampoo by gently massaging into hair and scalp. Rinse well.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive Ingredient Aqua/Water/Eau, Aloe Barbadensis Leaf Juice, Cocos Nucifera (Coconut) Oil, Betaine, Glycyrrhiza Glabra (Licorice) Root Powder, Glycerin, Cetyl Alcohol, Quaternium-91, Cetearyl Alcohol, Butyrospermum Parkii (Shea) Butter, Mangifera Indica (Mango) Seed Butter, Melia Azadirachta Seed Oil, Origanum Vulgare Leaf Extract, Nigella Sativa Seed Oil, Linum Usitatissimum (Linseed) Seed Extract, Camellia Sinensis Leaf Extract, Menthol, Keratin, Hydrolyzed Keratin, Piroctone Olamine, Polyquaternium-37, PPG-1 Trideceth-6, Phenoxyethanol, Caprylyl Glycol, Caprylic Acid, Fragrance/Parfum, Cetrimonium Methosulfate, Ethylhexyl Dimethyl PABA, Polyacrylamide, Propylene Glycol Dicaprylate/Dicaprate, 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 Conditioner PYRITHIONE ZINC WATER ALOE VERA LEAF COCONUT OIL GREEN TEA LEAF CETYL ALCOHOL CETOSTEARYL ALCOHOL BETAINE GLYCERIN MANGIFERA INDICA SEED BUTTER PADIMATE O LICORICE AZADIRACHTA INDICA SEED OIL POLYQUATERNIUM-37 (10000 MPA.S) LINSEED OIL PIROCTONE OLAMINE PIROCTONE CAPRYLIC ACID NIGELLA SATIVA SEED OIL PROPYLENE GLYCOL DICAPRYLATE/DICAPRATE PHENOXYETHANOL POLYACRYLAMIDE (10000 MW) MENTHOL QUATERNIUM-91 PPG-1 TRIDECETH-6 OREGANO BENZYL BENZOATE SHEA BUTTER .ALPHA.-HEXYLCINNAMALDEHYDE CETRIMONIUM METHOSULFATE CAPRYLYL GLYCOL PYRITHIONE ZINC PYRITHIONE ZINC AMINO ACIDS, HAIR KERATIN HYDROLYZED SHEEP WOOL KERATIN (2000 MW)

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 Conditioner (8 oz & 32 oz) Product NDC# 63766-301 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