Roots Professional - Topical Solution Hair Regrowth Treatment
Minoxidil 5%
Roots Hair Club, Llc
Human Otc Drug
NDC 73359-002Roots Professional - Topical Solution Hair Regrowth Treatment also known as Minoxidil 5% is a human otc drug labeled by 'Roots Hair Club, Llc'. National Drug Code (NDC) number for Roots Professional - Topical Solution Hair Regrowth Treatment is 73359-002. This drug is available in dosage form of Solution. The names of the active, medicinal ingredients in Roots Professional - Topical Solution Hair Regrowth Treatment drug includes Minoxidil - 5 g/100mL . The currest status of Roots Professional - Topical Solution Hair Regrowth Treatment drug is Active.
Drug Information:
| Drug NDC: | 73359-002 |
| 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: | Roots Professional - Topical Solution Hair Regrowth Treatment |
| 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 5% |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Roots Hair Club, Llc |
| 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: | 11 Sep, 2019 |
| 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: | ANDA076239 |
| 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: | Roots Hair Club, LLC
|
| 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. |
| UPC: | 0860000925044
|
| UPC stands for Universal Product Code. |
| 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 |
|---|
| 73359-002-01 | 1 BOTTLE in 1 BOX (73359-002-01) / 60 mL in 1 BOTTLE | 11 Sep, 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:
Hair regrowth treatment for men
Product Elements:
Roots professional - topical solution hair regrowth treatment minoxidil 5% isopropyl alcohol minoxidil minoxidil propylene glycol water
Indications and Usage:
Use use to regrow hair on the top of the scalp (vertex only, see pictures on side of carton).
Warnings:
For external use only. for use by men only. flammable: keep away from fire or flame
Do Not Use:
For external use only. for use by men only. flammable: keep away from fire or flame
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 expereinced 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 1ml with sprayer (6 sprays) 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 heart beat, faintness, or dissiness occurs sudden, unexplained weight gain occurs your hands of feet swell scalp irritation or redness occurs you get unwanted facial hair growth you do not see hair regrowth in 4 months
Package Label Principal Display Panel:
Box