Just For Men Control Gx Anti-dandruff
Pyrithione Zinc
Combe Incorporated
Human Otc Drug
NDC 11509-5225Just For Men Control Gx Anti-dandruff also known as Pyrithione Zinc is a human otc drug labeled by 'Combe Incorporated'. National Drug Code (NDC) number for Just For Men Control Gx Anti-dandruff is 11509-5225. This drug is available in dosage form of Shampoo. The names of the active, medicinal ingredients in Just For Men Control Gx Anti-dandruff drug includes Pyrithione Zinc - 10 mg/mL . The currest status of Just For Men Control Gx Anti-dandruff drug is Active.
Drug Information:
| Drug NDC: | 11509-5225 |
| 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: | Just For Men Control Gx Anti-dandruff |
| 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: | Combe Incorporated |
| 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 - 10 mg/mL
|
| 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: | 01 Jan, 2019 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 09 May, 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: | 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: | Combe Incorporated
|
| 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 |
|---|
| 11509-5225-1 | 118 mL in 1 BOTTLE (11509-5225-1) | 01 Jan, 2019 | 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:
Just for men control gx anti-dandruff pyrithione zinc pyrithione zinc pyrithione zinc water disodium lauryl sulfosuccinate decyl glucoside cetostearyl alcohol glycol stearate monoethanolamine cocamidopropyl hydroxysultaine guar hydroxypropyltrimonium chloride (1.7 substituents per saccharide) sodium cocoyl isethionate n,n-bis(2-hydroxyethyl)-p-phenylenediamine sulfate acetic acid aloe vera leaf 1,2,4-trihydroxybenzene cetearyl glucoside erythorbic acid sodium sulfite phenoxyethanol caprylyl glycol stearamide amp p-aminophenol panthenol sorbic acid
Indications and Usage:
Use helps prevent recurrence of flaking and itching associated with dandruff.
Warnings:
Warnings for external use only allergy alert do not use if you have known sensitivity to haircolouring products. this product contains hair dye. read thoroughly safety warnings and caution statements on carton and enclosed leaflet. when using this product avoid contact with eyes. if contact occurs, rinse eyes thoroughly with water. stop use and ask 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 this product contains hair dye. read thoroughly usage instructions on enclosed leaflet before using this product, you must perform a 48-hour skin allergy test according to enclosed leaflet wet hair apply shampoo and work into a lather leave on for about 1 minute rinse thoroughly for best anti-dandruff results, use at least twice a week or as directed by a doctor.
Stop Use:
Stop use and ask doctor if condition worsens, or does not improve after regular use of this product as directed.
Package Label Principal Display Panel:
Principal display panel reduces grey with each shampoo just for men ® control gx ® anti-dandruff grey reducing anti-dandruff shampoo 1% pyrithione zinc gradually reduces grey subtle, natural-looking results gently cleans & controls dandruff for any shade of hair. see back panel* 4 fl. oz. (118 ml) anti-dandruff + haircolour shampoo important: haircolour can cause allergic reactions. follow safety warnings on side panel. principal display panel reduces grey with each shampoo just for men® control gx® anti-dandruff grey reducing anti-dandruff shampoo 1% pyrithione zinc gradually reduces grey subtle, natural-looking results gently cleans & controls dandruff for any shade of hair. see back panel* 4 fl. oz. (118 ml) anti-dandruff + haircolour shampoo important: haircolour can cause allergic reactions. follow safety warnings on side panel. principal display panel reduces grey with each shampoo just for men® control gx® anti-dandruff grey reducing anti-dandruff shampoo 1% pyrithione zinc gradually reduces grey subtle, natural-looking results gently cleans & controls dandruff for any shade of hair. see back panel* 4 fl. oz. (118 ml) anti-dandruff + haircolour shampoo important: haircolour can cause allergic reactions. follow safety warnings on side panel.