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Nioxin scalp recovery medicating cleanser - Medication Information

Product NDC Code 69282-005
Drug Name

Nioxin scalp recovery medicating cleanser

Type Brand
Active Ingredients
Pyrithione zinc 1 g/100ml
Route TOPICAL
Dosage Form LOTION/SHAMPOO
RxCUI drug identifier 209884,
1487080
Application Number part358H
Labeler Name The Wella Corporation
Packages
Package NDC Code Description
69282-005-10 1000 ml in 1 bottle, plastic (69282-005-10)
69282-005-20 200 ml in 1 bottle, plastic (69282-005-20)
69282-005-50 1 bottle, plastic in 1 carton (69282-005-50) / 50 ml in 1 bottle, plastic
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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 For best results use at least twice a week or as directed by a doctor. Use daily for maximum dandruff control. Massage on to wet scalp and hair. Rinse. Repeat if desired.

Inactive ingredient

A list of inactive, non-medicinal ingredients in a drug product.
Inactive ingredients WATER, SODIUM LAURETH SULFATE, SODIUM LAURYL SULFATE, COCAMIDE MEA, ZINC CARBONATE, GLYCOL DISTEARATE, DIMETHICONE, CETYL ALCOHOL, GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE, SODIUM XYLENESULFONATE, MAGNESIUM SULFATE, SODIUM CHLORIDE, SODIUM BENZOATE, FRAGRANCE, DMDM HYDANTOIN, MENTHA PIPERITA (PEPPERMINT) OIL, MENTHOL, MENTHA ARVENSIS LEAF OIL, MAGNESIUM CARBONATE HYDROXIDE, BENZYL ALCOHOL, CAMELLIA SINENSIS LEAF EXTRACT, YEAST EXTRACT, LECITHIN, SACCHAROMYCES/MAGNESIUM FERMENT, BIOTIN/FOLIC ACID/CYANOCOBALAMIN/NIACINAMIDE/PANTOTHENIC ACID/PYRIDOXINE/RIBOFLAVIN/THIAMINE/YEAST POLYPEPTIDES, SACCHAROMYCES/IRON FERMENT, SACCHAROMYCES/COPPER FERMENT, SACCHAROMYCES/SILICON FERMENT, SACCHAROMYCES/ZINC FERMENT.

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 helps prevent recurrence of flaking, itching, irritation, scaling and redness 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.
Nioxin Scalp Recovery Medicating Cleanser Pyrithione Zinc WATER SODIUM LAURETH-3 SULFATE SODIUM LAURYL SULFATE COCO MONOETHANOLAMIDE ZINC CARBONATE GLYCOL DISTEARATE DIMETHICONE CETYL ALCOHOL GUAR HYDROXYPROPYLTRIMONIUM CHLORIDE (1.7 SUBSTITUENTS PER SACCHARIDE) SODIUM XYLENESULFONATE MAGNESIUM SULFATE, UNSPECIFIED FORM SODIUM CHLORIDE SODIUM BENZOATE DMDM HYDANTOIN PEPPERMINT OIL MENTHOL, UNSPECIFIED FORM MENTHA ARVENSIS LEAF OIL MAGNESIUM CARBONATE HYDROXIDE BENZYL ALCOHOL GREEN TEA LEAF YEAST, UNSPECIFIED 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.
PRINCIPAL DISPLAY PANEL - 200 mL Bottle Label NIOXIN ® SCALP RECOVERY ® For a dry, itchy scalp PYRITHIONE ZINC DANDRUFF AND SEBORRHEIC DERMATITIS SHAMPOO MEDICATING CLEANSER 100% FLAKE FREE ELIMINATION OF VISIBLE FLAKES WITH REGULAR USE 99405984 200 mL (6.76 FL OZ) PRINCIPAL DISPLAY PANEL - 200 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 Dist. by THE WELLA CORPORATION, WOODLAND HILLS, CA 91367

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 this and all drugs 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? 1-800-935-5273

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 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. Ask a doctor before use if you have a condition that covers a large area of the body. 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. Keep this and all drugs out of reach of children. If swallowed, get medical help or contact a Poison Control Center 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