Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men
Minoxidil
The Procter & Gamble Manufacturing Company
Human Otc Drug
NDC 69423-559Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men also known as Minoxidil is a human otc drug labeled by 'The Procter & Gamble Manufacturing Company'. National Drug Code (NDC) number for Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men is 69423-559. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men drug includes Minoxidil - 5 g/100mL . The currest status of Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men drug is Active.
Drug Information:
| Drug NDC: | 69423-559 |
| 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: | Head And Shoulders Scalp X Minoxidil Hair Regrowth Treatment For Men |
| 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: | Minoxidil |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | The Procter & Gamble Manufacturing Company |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Solution |
| 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: | MINOXIDIL - 5 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: | ANDA |
| 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 Jan, 2023 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 16 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: | ANDA091344 |
| 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, 2024 |
| 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: | The Procter & Gamble Manufacturing Company
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 311724
|
| 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. |
| NUI: | N0000175379
N0000175564
|
| Unique identifier applied to a drug concept within the National Drug File Reference Terminology (NDF-RT). |
| UNII: | 5965120SH1
|
| 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. |
| Pharmacologic Class EPC: | Arteriolar Vasodilator [EPC]
|
| Established pharmacologic class associated with an approved indication of an active moiety (generic drug) that the FDA has determined to be scientifically valid and clinically meaningful. Takes the form of the pharmacologic class, followed by `[EPC]` (such as `Thiazide Diuretic [EPC]` or `Tumor Necrosis Factor Blocker [EPC]`. |
| Pharmacologic Class PE: | Arteriolar Vasodilation [PE]
|
| Physiologic effect or pharmacodynamic effect—tissue, organ, or organ system level functional activity—of the drug’s established pharmacologic class. Takes the form of the effect, followed by `[PE]` (such as `Increased Diuresis [PE]` or `Decreased Cytokine Activity [PE]`. |
| Pharmacologic Class: | Arteriolar Vasodilation [PE]
Arteriolar Vasodilator [EPC]
|
| These are the reported pharmacological class categories corresponding to the SubstanceNames listed above. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 69423-559-01 | 3 BOTTLE, DROPPER in 1 CARTON (69423-559-01) / 60 mL in 1 BOTTLE, DROPPER | 15 Jan, 2023 | 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 hair regrowth treatment for men
Product Elements:
Head and shoulders scalp x minoxidil hair regrowth treatment for men minoxidil minoxidil minoxidil dehydrated alcohol water propylene glycol
Indications and Usage:
Use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton)
Warnings:
Warnings for external use only. flammable: keep away from fire or flame do not use if you are a woman your amount of hair loss is different than that shown on side of this carton, or your hair loss is on the front of the scalp. minoxidil topical solution 5% is not intended for frontal baldness or receding hairline. you have no family history of hair loss your hair loss is sudden and/or patchy you do not know the reason for your hair loss you are under 18 years of age. do not use on babies and children your scalp is red, inflamed, infected, irritated or painful you use other medicines on the scalp ask a doctor before use if you have heart disease when using this product do not apply on other parts of the body avoid contact with the eyes. in case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. results may occur at 2 months with twice a day usage. for some men, you may n
Read more...eed to use this product for at least 4 months before you see results. the amount of hair regrowth is different for each person. this product will not work for all men. stop use and ask a doctor if chest pain, rapid heartbeat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occurs you do not see hair regrowth in 4 months may be harmful if used when pregnant or breast-feeding keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. (1-800-222-1222)
Do Not Use:
Warnings for external use only. flammable: keep away from fire or flame do not use if you are a woman your amount of hair loss is different than that shown on side of this carton, or your hair loss is on the front of the scalp. minoxidil topical solution 5% is not intended for frontal baldness or receding hairline. you have no family history of hair loss your hair loss is sudden and/or patchy you do not know the reason for your hair loss you are under 18 years of age. do not use on babies and children your scalp is red, inflamed, infected, irritated or painful you use other medicines on the scalp ask a doctor before use if you have heart disease when using this product do not apply on other parts of the body avoid contact with the eyes. in case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. results may occur at 2 months with twice a day usage. for some men, you may need to use this product for at least 4 months before you see results. the amount of hair regrowth is different for each person. this product will not work for all men. stop use and ask a doctor if chest pain, rapid heartbeat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occurs you do not see hair regrowth in 4 months may be harmful if used when pregnant or breast-feeding keep out of reach of children. if swallowed, get medical help or contact a poison control center right away. (1-800-222-1222)
When Using:
When using this product do not apply on other parts of the body avoid contact with the eyes. in case of accidental contact, rinse eyes with large amounts of cool tap water. some people have experienced changes in hair color and/or texture it takes time to regrow hair. results may occur at 2 months with twice a day usage. for some men, you may need to use this product for at least 4 months before you see results. the amount of hair regrowth is different for each person. this product will not work for all men.
Dosage and Administration:
Directions apply one ml with dropper 2 times a day directly onto the scalp in the hair loss area using more or more often will not improve results continued use is necessary to increase and keep your hair regrowth, or hair loss will begin again
Stop Use:
Stop use and ask a doctor if chest pain, rapid heartbeat, faintness, or dizziness occurs sudden, unexplained weight gain occurs your hands or feet swell scalp irritation or redness occurs unwanted facial hair growth occurs you do not see hair regrowth in 4 months
Package Label Principal Display Panel:
Principal display panel - carton head & shoulders scalp x minoxidil topical solution usp, 5% hair regrowth treatment for men extra strength topical solution clinically proven to help regrow hair reactivates hair follicles to stimulate regrowth three month supply unscented 3 - 60 ml (2 fl oz) bottles total 180 ml (6 fl oz) hs
Further Questions:
Questions or comments? 1-800-723-9569