Nioxin Scalp Recovery Anti-dandruff System
Pyrithione Zinc
Wella Operations Us Llc
Human Otc Drug
NDC 82157-006Nioxin Scalp Recovery Anti-dandruff System also known as Pyrithione Zinc is a human otc drug labeled by 'Wella Operations Us Llc'. National Drug Code (NDC) number for Nioxin Scalp Recovery Anti-dandruff System is 82157-006. This drug is available in dosage form of Kit. The names of the active, medicinal ingredients in Nioxin Scalp Recovery Anti-dandruff System drug includes . The currest status of Nioxin Scalp Recovery Anti-dandruff System drug is Active.
Drug Information:
| Drug NDC: | 82157-006 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Nioxin Scalp Recovery Anti-dandruff System |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Pyrithione Zinc |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Wella Operations Us Llc |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Kit |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | |
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | |
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | OTC MONOGRAPH FINAL |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (ANDA), BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
| Marketing Start Date: | 01 Dec, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 19 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Application Number: | M032 |
| This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null. |
| Listing Expiration Date: | 31 Dec, 2023 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | Wella Operations US LLC
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 209884
1043014
1245090
1245095
1487080
1593569
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 82157-006-99 | 1 KIT in 1 CARTON (82157-006-99) * 200 mL in 1 BOTTLE, PLASTIC (82157-004-20) * 100 mL in 1 BOTTLE, PLASTIC (82157-005-10) * 200 mL in 1 BOTTLE, PLASTIC (82157-003-20) | 01 Dec, 2022 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Purpose:
Purpose anti-dandruff
Product Elements:
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
Indications and Usage:
Uses helps prevent recurrence of flaking and itching associated with dandruff
Warnings:
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.
When Using:
When using this product avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water.
Dosage and Administration:
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.
Stop Use:
Stop use and ask a doctor if condition worsens or does not improve after regular use of this product as directed.
Package Label Principal Display Panel:
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
Further Questions:
Questions? 1-800-935-5273