Biogram Anti Hair Loss Ampoule
Stem Cell Germinal Fluid
Beijing Xinghui Regeneration Technology Co., Ltd.
Human Otc Drug
NDC 83117-003Biogram Anti Hair Loss Ampoule also known as Stem Cell Germinal Fluid is a human otc drug labeled by 'Beijing Xinghui Regeneration Technology Co., Ltd.'. National Drug Code (NDC) number for Biogram Anti Hair Loss Ampoule is 83117-003. This drug is available in dosage form of Powder, For Solution. The names of the active, medicinal ingredients in Biogram Anti Hair Loss Ampoule drug includes Allogenic Adipose Derived Mesenchymal Stem Cells (mscs) Exosomes - 15 mg/3mL . The currest status of Biogram Anti Hair Loss Ampoule drug is Active.
Drug Information:
| Drug NDC: | 83117-003 |
| 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: | Biogram Anti Hair Loss Ampoule |
| 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: | Stem Cell Germinal Fluid |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Beijing Xinghui Regeneration Technology Co., Ltd. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Powder, For 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: | ALLOGENIC ADIPOSE DERIVED MESENCHYMAL STEM CELLS (MSCS) EXOSOMES - 15 mg/3mL
|
| 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: | 20 Nov, 2022 |
| 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. |
| 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: | Beijing Xinghui Regeneration Technology Co., LTD.
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 377D2SLL5Z
|
| 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 |
|---|
| 83117-003-02 | 20 BOTTLE in 1 BOX (83117-003-02) / 3 mL in 1 BOTTLE | 20 Nov, 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:
To relieve and prevent hair loss symptoms due to: ⢠androgen alopecia ⢠seborrheic alopecia
Product Elements:
Biogram anti hair loss ampoule stem cell germinal fluid allogenic adipose derived mesenchymal stem cells (mscs) exosomes allogenic adipose derived mesenchymal stem cells (mscs) exosomes water histidinal, l- polysorbate 80 mannitol
Indications and Usage:
To relieve and prevent hair loss symptoms due to androgen alopecia and seborrheic alopecia. mix agent i with agent â
¡, after completely dissolving, gently apply an appropriate amount to the scalp, focusing on the key areas.
Warnings:
1. during the application of this product, if abnormal symptoms or side effects occur, such as erythema, redness, swelling or itching due to direct light, please seek for medical advice and consult a professional doctor immediately. 2. avoid using it directly on the wounded parts. 3. keep the product out of reach of children. 4. if it accidentally gets into the eyes, immediately wash and flush eyes with clean water. 5. this product may cause skin and body allergies or aggravate existing abnormal skin reactions (edema, inflammation, etc.). if you have experienced prior allergic reactions,consult a professional doctor or pharmacist before use.
Do Not Use:
1. during the application of this product, if abnormal symptoms or side effects occur, such as erythema, redness, swelling or itching due to direct light, please seek for medical advice and consult a professional doctor immediately. 2. avoid using it directly on the wounded parts. 3. keep the product out of reach of children. 4. if it accidentally gets into the eyes, immediately wash and flush eyes with clean water. 5. this product may cause skin and body allergies or aggravate existing abnormal skin reactions (edema, inflammation, etc.). if you have experienced prior allergic reactions,consult a professional doctor or pharmacist before use.
Dosage and Administration:
Mix agent i with agent â
¡, after completely dissolving, gently apply an appropriate amount to the scalp, focusing on the key areas. once daily.
Stop Use:
Stop use and ask a doctor if condition worsens or does not improve after regular use as directed.
Package Label Principal Display Panel:
20bottle in 1 box 20bottle in 1 box