Hairfx Hair Growth Foam
Minoxidil
Guangzhou Jianyuan Biological Technology.co.,ltd
Human Otc Drug
NDC 81653-003Hairfx Hair Growth Foam also known as Minoxidil is a human otc drug labeled by 'Guangzhou Jianyuan Biological Technology.co.,ltd'. National Drug Code (NDC) number for Hairfx Hair Growth Foam is 81653-003. This drug is available in dosage form of Aerosol, Foam. The names of the active, medicinal ingredients in Hairfx Hair Growth Foam drug includes Minoxidil - 5 g/100g . The currest status of Hairfx Hair Growth Foam drug is Active.
Drug Information:
| Drug NDC: | 81653-003 |
| 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: | Hairfx Hair Growth Foam |
| 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: | Guangzhou Jianyuan Biological Technology.co.,ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Aerosol, Foam |
| 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/100g
|
| 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: | UNAPPROVED DRUG OTHER |
| 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: | 23 Mar, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 07 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. |
| 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: | Guangzhou Jianyuan Biological Technology.Co.,Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 645146
|
| 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 |
|---|
| 81653-003-01 | 60 g in 1 BOTTLE (81653-003-01) | 27 Mar, 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:
Stronger thicker longer hair reduce hair loss restore thinning hair the foam is for somepeople who have a general thinning of hair on the top of the scalp(vertex only, asshown below). not intendedfor frontal baldness or areceding hairline. the foamhas been shown to regrowhair in some people with thefollowing degrees of thinninghair or hair loss. lf you have more hair loss or hair loss in a place different than shown above, foam may not work. 1122
Product Elements:
Hairfx hair growth foam minoxidil water safflower ligusticum sinense subsp. chuanxiong root ligustrum lucidum fruit angelica sinensis root capsaicin biotin pork collagen minoxidil minoxidil panax ginseng fruit frangula alnus bark glycyrrhiza uralensis root platycladus orientalis whole reynoutria multiflora root
Indications and Usage:
For hair loss apply half a capful once daily to directly to the scalp in the hair loss area massage into scalp with fingers. then wash hands well.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
Warnings:
For adult external use only. flammable. keep away fromheat or flame. do not use ·pregnant women and children. ·on open skin wounds
Warnings and Cautions:
When using this product keep out of eyes, ears, andmouth. in case of contact with eyes, rinse eyes thoroughlywith water. stop use and ask a doctor if irritation or rash occurs.these may be signs of a serious condition.
Dosage and Administration:
This package contains. one 60g (2.11 fl oz) cans of foam (one month supply) apply half a capful once daily to directly to the scalp in the hair loss area massage into scalp with fingers
Stop Use:
Do not use - pregnant women and children. - on open skin wounds when using this product keep out of eyes,ears, and mouth. ln case of contact with eyes, rinse eyes thoroughly with water. stop use and ask a doctor if irritation or rashoccurs.these may be signs of a serious condition. keep out of reach of children. if swallowed, get medical help or contact a poison controlcenter right away.
Package Label Principal Display Panel:
60g