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Product NDC Code | 82157-005 | ||||
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Drug Name | Nioxin scalp recovery soothing serum |
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Type | Brand | ||||
Active Ingredients |
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Route | TOPICAL | ||||
Dosage Form | LOTION | ||||
RxCUI drug identifier | 1245090, 1245095 |
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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 0.1%
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 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.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 Soothing Serum Pyrithione zinc FORMALDEHYDE/SODIUM NAPHTHALENESULFONATE COPOLYMER (3000 MW) BENZYL SALICYLATE ISOMETHYL-.ALPHA.-IONONE LECITHIN, SOYBEAN URTICA DIOICA LEAF ACHILLEA MILLEFOLIUM ROSEMARY EQUISETUM ARVENSE BRANCH POTASSIUM SORBATE HYDROXYETHYL CELLULOSE, UNSPECIFIED BUTYLATED HYDROXYTOLUENE WATER STEARAMIDOPROPYL DIMETHYLAMINE CETYL ALCOHOL BENZYL ALCOHOL PHENOXYETHANOL STEARYL ALCOHOL POLYETHYLENE OXIDE 100000 DIMETHICONE CETOSTEARYL ALCOHOL METHYLPARABEN PROPYLPARABEN GLYCERYL MONOSTEARATE OLEYL ALCOHOL CITRIC ACID MONOHYDRATE POLYSORBATE 60 PEPPERMINT OIL .ALPHA.-TOCOPHEROL ACETATE MENTHA ARVENSIS LEAF OIL GREEN TEA LEAF SODIUM PHOSPHATE BETULA PUBESCENS LEAF SODIUM BENZOATE INOSITOL DISTEARYLDIMONIUM CHLORIDE BIOTIN PROPYLENE GLYCOL .ALPHA.-HEXYLCINNAMALDEHYDE LIMONENE, (+/-)- SILICON DIOXIDE SODIUM PHOSPHATE, DIBASIC, ANHYDROUS PANTHENOL NIACINAMIDE LINALOOL, (+/-)- GERANIOL DMDM HYDANTOIN MALTODEXTRIN CARBOXYMETHYLCELLULOSE SODIUM ANHYDROUS DEXTROSE LACTIC ACID TARTARIC ACID SAGE CALCIUM PANTOTHENATE CARAMEL 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 SOOTHING SERUM STEP 3 SCALP RECOVERY FOR ITCHY FLAKY SCALP COMBATS DANDRUFF FROM THE 1ST USE 100 mL (3.38 FL OZ) 82157-005 PDP 82157-005 Back
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® SOOTHING SERUM WITH PYRITHIONE ZINC IS A LEAVE-ON TREATMENT THAT HELPS RELIEVE DANDRUFF. 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