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| Product NDC Code | 82157-006 | ||||
|---|---|---|---|---|---|
| Drug Name | Nioxin scalp recovery anti-dandruff system |
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| Type | Brand | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 209884, 1043014, 1245090, 1245095, 1487080, 1593569 |
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| Application Number | M032 | ||||
| Labeler Name | Wella Operations US LLC | ||||
| 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% (Medicating Cleanser) Pyrithione zinc 0.5% (Moisturizing Conditioner) Pyrithione zinc 0.1% (Soothing Serum)
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 MEDICATING CLEANSER 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. MOISTURIZING CONDITIONER For best results, use at least twice a week or as directed by a doctor Use daily for maximum dandruff control Apply to wet scalp and hair. Leave for 1-3 minutes. Rinse well. SOOTHING SERUM Apply after usage of Medicating Cleanser and Moisturizing Conditioner to scalp. Apply to affected areas one to four times daily or as directed by a doctor.
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.MEDICATING CLEANSER 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. MOISTURIZING CONDITIONER Inactive ingredients water, stearyl alcohol, cetyl alcohol, stearamidopropyl dimethylamine, dimethicone, glutamic acid, benzyl alcohol, phenoxyethanol, fragrance, methylparaben, mentha arvensis leaf oil, mentha piperita (peppermint) oil, citric acid, propylene glycol, linalool, hexyl cinnamal, camellia sinensis leaf extract, limonene, sodium polynaphthalenesulfonate, geraniol, DMDM hydantoin, cellulose gum, yeast extract, niacinamide, panthenol, biotin, lecithin, tocopheryl acetate, ethoxydiglycol, maltodextrin, glucose, propylparaben, lactic acid, sodium benzoate, equisetum arvense extract, rosmarinus officinalis (rosemary) leaf extract, salvia officinalis (sage) leaf extract, urtica dioica (nettle) extract, achillea millefolium extract, betula alba leaf extract, potassium sorbate, inositol, calcium pantothenate, tartaric acid, caramel. SOOTHING SERUM Inactive ingredients water, cetyl alcohol, stearamidopropyl dimethylamine, stearyl alcohol, distearyldimonium chloride, hydroxyethylcellulose, benzyl alcohol, phenoxyethanol, PEG-2M, dimethicone, fragrance, cetearyl alcohol, methylparaben, glyceryl stearate, oleyl alcohol, mentha arvensis leaf oil, mentha piperita (peppermint) oil, citric acid, polysorbate 60, propylene glycol, camellia sinensis leaf extract, linalool, hexyl cinnamal, limonene, silica, geraniol, benzyl salicylate, alpha-isomethyl ionone, sodium polynaphthalenesulfonate, yeast extract, disodium phosphate, niacinamide, panthenol, biotin, lecithin, tocopheryl acetate, ethoxydiglycol, DMDM hydantoin, maltodextrin, cellulose gum, sodium phosphate, BHT, glucose, propylparaben, lactic acid, sodium benzoate, betula alba leaf extract, achillea millefolium extract, utica dioica (nettle) extract, salvia officinalis (sage) leaf extract, rosmarinus officinalis (rosemary) leaf extract, equisetum arvense extract, potassium sorbate, calcium pantothenate, inositol, caramel, tartaric acid
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 Anti-Dandruff System Pyrithione zinc Nioxin Scalp Recovery Medicating Cleanser Pyrithione zinc LECITHIN, SOYBEAN COCAMIDOPROPYL BETAINE MAGNESIUM LAURETH SULFATE ALPHA-TOCOPHEROL ACETATE INOSITOL LACTIC ACID METHYLPARABEN SODIUM BENZOATE MENTHA ARVENSIS LEAF OIL BENZYL ALCOHOL PROPYLENE GLYCOL LIMONENE, (+/-)- DEXTROSE, UNSPECIFIED FORM PROPYLPARABEN SODIUM CHLORIDE FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) YEAST, UNSPECIFIED SODIUM HYDROXIDE SODIUM LAURETH-8 SULFATE SAGE CALCIUM PANTOTHENATE MALTODEXTRIN EQUISETUM ARVENSE BRANCH CARAMEL NIACINAMIDE ACHILLEA MILLEFOLIUM SODIUM OLEYL SULFATE MAGNESIUM OLETH SULFATE DMDM HYDANTOIN PEPPERMINT OIL GREEN TEA LEAF GERANIOL BIOTIN DIETHYLENE GLYCOL MONOETHYL ETHER .ALPHA.-HEXYLCINNAMALDEHYDE BETULA PUBESCENS LEAF POTASSIUM SORBATE BENZOIC ACID CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM TARTARIC ACID PANTHENOL SODIUM LAURETH-3 SULFATE LINALOOL, (+/-)- WATER PEG-3 DISTEARATE POLYQUATERNIUM-10 (400 MPA.S AT 2%) URTICA DIOICA LEAF ROSEMARY ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER MAGNESIUM LAURETH-8 SULFATE CITRIC ACID MONOHYDRATE PYRITHIONE ZINC PYRITHIONE ZINC Nioxin Scalp Recovery Moisturizing Conditioner Pyrithione zinc LECITHIN, SOYBEAN SAGE CALCIUM PANTOTHENATE DIMETHICONE METHYLPARABEN CITRIC ACID MONOHYDRATE ROSEMARY GREEN TEA LEAF DIETHYLENE GLYCOL MONOETHYL ETHER INOSITOL TARTARIC ACID LIMONENE, (+/-)- EQUISETUM ARVENSE BRANCH PHENOXYETHANOL MALTODEXTRIN POTASSIUM SORBATE ACHILLEA MILLEFOLIUM .ALPHA.-HEXYLCINNAMALDEHYDE GERANIOL FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) PROPYLPARABEN PEPPERMINT OIL NIACINAMIDE DMDM HYDANTOIN LACTIC ACID SODIUM BENZOATE CARAMEL LINALOOL, (+/-)- URTICA DIOICA LEAF ALPHA-TOCOPHEROL ACETATE PANTHENOL BIOTIN PROPYLENE GLYCOL WATER MENTHA ARVENSIS LEAF OIL YEAST, UNSPECIFIED BETULA PUBESCENS LEAF CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM DEXTROSE, UNSPECIFIED FORM STEARYL ALCOHOL CETYL ALCOHOL STEARAMIDOPROPYL DIMETHYLAMINE GLUTAMIC ACID BENZYL ALCOHOL PYRITHIONE ZINC PYRITHIONE ZINC Nioxin Scalp Recovery Soothing Serum Pyrithione zinc URTICA DIOICA LEAF EQUISETUM ARVENSE BRANCH CETYL ALCOHOL YEAST, UNSPECIFIED ROSEMARY BUTYLATED HYDROXYTOLUENE PROPYLPARABEN PROPYLENE GLYCOL LIMONENE, (+/-)- SILICON DIOXIDE PANTHENOL NIACINAMIDE LINALOOL, (+/-)- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) WATER CARAMEL ISOMETHYL-.ALPHA.-IONONE CETOSTEARYL ALCOHOL METHYLPARABEN PEPPERMINT OIL ALPHA-TOCOPHEROL ACETATE BENZYL ALCOHOL PHENOXYETHANOL STEARYL ALCOHOL DIMETHICONE POTASSIUM SORBATE BIOTIN ANHYDROUS DEXTROSE LECITHIN, SOYBEAN ACHILLEA MILLEFOLIUM HYDROXYETHYL CELLULOSE, UNSPECIFIED STEARAMIDOPROPYL DIMETHYLAMINE POLYSORBATE 60 POLYETHYLENE OXIDE 100000 OLEYL ALCOHOL MENTHA ARVENSIS LEAF OIL SODIUM PHOSPHATE, DIBASIC, ANHYDROUS DMDM HYDANTOIN MALTODEXTRIN TARTARIC ACID SAGE SODIUM BENZOATE INOSITOL BENZYL SALICYLATE GLYCERYL MONOSTEARATE CITRIC ACID MONOHYDRATE GREEN TEA LEAF SODIUM PHOSPHATE DISTEARYLDIMONIUM CHLORIDE .ALPHA.-HEXYLCINNAMALDEHYDE GERANIOL BETULA PUBESCENS LEAF LACTIC ACID CALCIUM PANTOTHENATE 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® SCALP RECOVERY ANTI-DANDRUFF SYSTEM FOR ITCHY, FLAKY SCALP COMBATS DANDRUFF FROM THE 1ST USE STEP 1 STEP 2 STEP 3 PYRITHIONE ZINC MEDICATING CLEANSER PYRITHIONE ZINC MOISTURIZING CONDITIONER PYRITHIONE ZINC SOOTHING SERUM 200 mL (6.76 FL OZ ) 200 mL ( 6.76 FL OZ) 100 mL ( 3.38 FL OZ) 82157-006 FOCA KIT PDP
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
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