Suave Men 2 In 1 Pure Power Antidandruff
Pyrithione Zinc
Conopco Inc. D/b/a Unilever
Human Otc Drug
NDC 64942-1437Suave Men 2 In 1 Pure Power Antidandruff also known as Pyrithione Zinc is a human otc drug labeled by 'Conopco Inc. D/b/a Unilever'. National Drug Code (NDC) number for Suave Men 2 In 1 Pure Power Antidandruff is 64942-1437. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Suave Men 2 In 1 Pure Power Antidandruff drug includes Pyrithione Zinc - 1 g/100mL . The currest status of Suave Men 2 In 1 Pure Power Antidandruff drug is Active.
Drug Information:
| Drug NDC: | 64942-1437 |
| 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: | Suave Men 2 In 1 Pure Power Antidandruff |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Proprietary Name Base: | Suave |
| The base of the Brand/Proprietary name excluding its suffix. |
| Proprietary Name Suffix: | Men 2 in 1 Pure Power Antidandruff |
| A suffix to the proprietary name, a value here should be appended to the ProprietaryName field to obtain the complete name of the product. This suffix is often used to distinguish characteristics of a product such as extended release (“XR”) or sleep aid (“PM”). Although many companies follow certain naming conventions for suffices, there is no recognized standard. |
| 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: | Conopco Inc. D/b/a Unilever |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Shampoo |
| 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: | PYRITHIONE ZINC - 1 g/100mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| 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: | 15 Dec, 2015 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 15 Jan, 2025 |
| 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: | part358H |
| 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: | Conopco Inc. d/b/a Unilever
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 209884
|
| 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: | R953O2RHZ5
|
| 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 |
|---|
| 64942-1437-1 | 828 mL in 1 CONTAINER (64942-1437-1) | 15 Dec, 2015 | N/A | No |
| 64942-1437-2 | 373 mL in 1 CONTAINER (64942-1437-2) | 15 Dec, 2015 | 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 antidandruff
Product Elements:
Suave men 2 in 1 pure power antidandruff pyrithione zinc zinc sulfate carbomer homopolymer, unspecified type water sodium laureth sulfate cocamidopropyl betaine sodium chloride dmdm hydantoin triethanolamine dodecylbenzenesulfonate citric acid monohydrate ppg-9 methylchloroisothiazolinone methylisothiazolinone guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) dimethiconol (41 mpa.s) butylene glycol iodopropynyl butylcarbamate pyrithione zinc pyrithione zinc
Indications and Usage:
Use controls scalp itching and flaking 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 wet hair, lather, rinse, and repeat. for best results, use at least twice a week 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:
Package suave power anti-dandruff sh cd
Further Questions:
Questions or comments? call us at 1-800-782-8301 mon - fri 8:30-6:00 pm est