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Product NDC Code | 82157-003 | ||||
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Drug Name | Nioxin scalp recovery medicating cleanser |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | SHAMPOO | ||||
RxCUI drug identifier | 209884, 1487080 |
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Application Number | M032 | ||||
Labeler Name | Wella Operations US LLC | ||||
Packages |
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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, PEG-3 distearate, sodium laureth-8 sulfate, sodium chloride, cocamidopropyl betaine, acrylates/steareth-20 methacrylate copolymer, magnesium laureth-8 sulfate, magnesium laureth sulfate, sodium oleth sulfate, fragrance, sodium benzoate, citric acid, DMDM hydantoin, mentha arvensis leaf oil, mentha piperita (peppermint) oil, magnesium oleth sulfate, sodium hydroxide, polyquaternium-10, propylene glycol, benzoic acid, linalool, hexyl cinnamal, camellia sinensis leaf extract, sodium polynaphthalenesulfonate, benzyl alcohol, limonene, geraniol, cellulose gum, yeast extract, niacinamide, tocopheryl acetate, panthenol, biotin, lecithin, ethoxydiglycol, maltodextrin, methylparaben, glucose, propylparaben, lactic acid, achillea millefolium extract, betula alba leaf extract, urtica dioica (nettle) extract, salvia officinalis (sage) leaf extract, rosmarinus officinalis (rosemary) leaf extract, equisetum arvense extract, potassium sorbate, calcium pantothenate, inositol, tartaric acid, caramel.
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 and itching associated with dandruff.
Purpose
Information about the drug product’s indications for use.Purpose Anti-dandruff
Spl product data elements
Usually a list of ingredients in a drug product.Nioxin Scalp Recovery Medicating Cleanser Pyrithione zinc POLYQUATERNIUM-10 (400 MPA.S AT 2%) FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) CITRIC ACID MONOHYDRATE PROPYLENE GLYCOL LIMONENE, (+/-)- SODIUM OLEYL SULFATE COCAMIDOPROPYL BETAINE ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER MAGNESIUM LAURETH-8 SULFATE MAGNESIUM LAURETH SULFATE SODIUM HYDROXIDE BIOTIN SODIUM LAURETH-8 SULFATE GERANIOL .ALPHA.-TOCOPHEROL ACETATE DIETHYLENE GLYCOL MONOETHYL ETHER ROSEMARY INOSITOL LACTIC ACID BETULA PUBESCENS LEAF POTASSIUM SORBATE SAGE ACHILLEA MILLEFOLIUM CALCIUM PANTOTHENATE BENZOIC ACID .ALPHA.-HEXYLCINNAMALDEHYDE CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM MALTODEXTRIN URTICA DIOICA LEAF EQUISETUM ARVENSE BRANCH TARTARIC ACID CARAMEL PROPYLPARABEN LECITHIN, SOYBEAN NIACINAMIDE PANTHENOL METHYLPARABEN DEXTROSE, UNSPECIFIED FORM SODIUM CHLORIDE MAGNESIUM OLETH SULFATE LINALOOL, (+/-)- WATER SODIUM LAURETH-3 SULFATE PEG-3 DISTEARATE SODIUM BENZOATE DMDM HYDANTOIN PEPPERMINT OIL MENTHA ARVENSIS LEAF OIL 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.NIOXIN ® PYRITHIONE ZINC MEDICATING CLEANSER STEP 1 SCALP RECOVERY® FOR ITCHY, FLAKY SCALP COMBATS DANDRUFF FROM THE 1ST USE 200 mL (6.76 FL OZ) 82157-003 PDP 82157-003 back rev
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
NIOXIN SCALP RECOVERY® MEDICATING CLEANSER IS AN ANTIDANDRUFF SHAMPOO WITH PYRITHIONE ZINC THAT HELPS PREVENT AND RELIEVE THE SYMPTOMS OF DANDRUFF, SUCH AS SCALP ITCHING AND FLAKING. MADE IN U.S.A. of U.S. and/or imported ingredients Dist. Wella Operations US LLC, Calabasas, CA 91302 www.nioxin.com 1-800-935-5273
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? 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. 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 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