Vial Kit3.98
Chitosan
Oxytical
Human Otc Drug
NDC 80851-302Vial Kit3.98 also known as Chitosan is a human otc drug labeled by 'Oxytical'. National Drug Code (NDC) number for Vial Kit3.98 is 80851-302. This drug is available in dosage form of Liquid. The names of the active, medicinal ingredients in Vial Kit3.98 drug includes Chitosan Medium Molecular Weight (200-400 Mpa.s) - 99.99 mg/100mL . The currest status of Vial Kit3.98 drug is Active.
Drug Information:
| Drug NDC: | 80851-302 |
| 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: | Vial Kit3.98 |
| 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: | Chitosan |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Oxytical |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Liquid |
| 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: | CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S) - 99.99 mg/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: | 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: | 12 Nov, 2020 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 14 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: | Oxytical
|
| 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: | 5GV09YMO52
|
| 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 |
|---|
| 80851-302-01 | .02 mL in 1 BOTTLE, GLASS (80851-302-01) | 12 Nov, 2020 | 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 skin regeneration and wrinkle relief
Product Elements:
Vial kit3.98 chitosan water chitosan medium molecular weight (200-400 mpa.s) chitosan medium molecular weight (200-400 mpa.s)
Indications and Usage:
Use the skin's surface appears firmer and smoother with a more youthful look. remodels the facial contours and reduces the thickness of subcutaneous fatty tissue helping to reduce the "double chin effect" providing you with a youthful complexion. reinforces skin elasticity to provide plump and radiant complexion.
Warnings:
Warnings for external use only. keep away from heat.
When Using:
When using although it can be used immediately after melting, it is recommended to use after 12 hours after mixing the product and closing it with an elastomer tube after mixing the product to increase the activity and maximize the efficacy due to the nature of the formulation. after blending, only the elastomer tube is closed and stored at room temperature fresh out of direct sunlight. (up to 21 days)
Dosage and Administration:
Directions [preparation stage] after cleansing, use toner to clean up the skin. it must be used only after cleansing is complete, and especially pay attention to the cleanliness of your hands. if you use it after exfoliation, you can get more satisfactory results, and it is more effective if you give a simple massage before use. [application stage] 1. prepare core peptide(1st), stable chitin(2nd) and a syringe. 2. core peptide(1st) only opens the plastic cap. 3. a syringe inlet is injected into the center of the hole at the top of the core peptide(1st) to suction. (total 3ml based on syringe). after the syringe is removed, the inlet is automatically sealed to prevent outside air from entering. 4. open the stable chitin(2nd) after referring to the precautions and inject the core peptide(1st). due to the nature of the stable chitin component, it is not soluble in ampoule other than core peptide. (not compatible) 5. close the vial opening of the stable chitin(2nd) with an elastomer tube a
Read more...nd shake to dissolve the stable chitin. check with eyes and if the stable chitin component does not appear in the form of a thread (slightly thick), apply it to the skin.
Stop Use:
Stop using stop use and ask a physician if skin irritation and redness occurs more that 72 hours.
Package Label Principal Display Panel:
Package label 0.02ml ndc:80851-302-01 label