Vial Kit3.98
NDC 80851-302

View dosage, usage, ingredients, routes, and UNII mappings.

Product Information

This product is EXCLUDED from the official NDC directory because the listing data was inactivated by the FDA.

Vial Kit3.98 is a UNAPPROVED DRUG OTHER-approved product labeled by Oxytical. This product is primarily utilized in pharmaceutical processing or compounding. It is supplied as a product. This product entry covers the primary NDC 80851-302 and its associated package configuration. This profile includes active and inactive ingredient UNII references and FDA labeling data.

Primary Identification

NDC Product Code:
80851-302
Proprietary Name:
Vial Kit3.98
Product Type: [3]
INACTIVATED PRODUCT and EXCLUDED the from NDC Directory
Code Navigator:

Labeler & Regulatory Data

Labeler Name: [5]
Labeler Code:
80851
Marketing Category: [8]
UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.

Marketing Timeline

Start Marketing Date: [9]
11-12-2020
Listing Expiration Date: [11]
12-31-2023
Exclude Flag: [12]
I

Code Structure Chart

Product Details

What is NDC 80851-302?

The NDC code 80851-302 is assigned by the FDA to the product Vial Kit3.98. This pharmaceutical product is labeled by Oxytical and is currently categorized as listed product. In terms of distribution, this product is available in a single package configuration. The associated package NDC(s) include: 80851-302-01. Beyond standard identification, this entry provides technical data including pharmacologic classes, UNII ingredient references, and RxNorm cross-referencing for healthcare systems.

What are the uses of this product?

[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 and 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.

Which are the associated UNII Codes?

The UNII codes for the active ingredients in this product are:

  • CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S) (UNII: 5GV09YMO52)
  • CHITOSAN MEDIUM MOLECULAR WEIGHT (200-400 MPA.S) (UNII: 5GV09YMO52) (Active Moiety)

Which are the Inactive Ingredients associated UNII Codes?

The inactive ingredients are all the component of a medicinal product OTHER than the active ingredient(s). The acronym "UNII" stands for “Unique Ingredient Identifier” and is used to identify each inactive ingredient present in a product. The UNII codes for the inactive ingredients in this product are:

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Product & Regulatory Definitions
What is the Labeler Name? Name of Company corresponding to the labeler code segment of the Product NDC.
What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/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.
What is the Start Marketing Date? This is the date that the labeler indicates was the start of its marketing of the drug product.
What is the Listing Expiration Date? This is the date when the listing record will expire if not updated or certified by the product labeler.
What is the NDC Exclude Flag? This field indicates whether the product has been removed/excluded from the NDC Directory for failure to respond to FDA"s requests for correction to deficient or non-compliant submissions, or because the listing certification is expired, or because the listing data was inactivated by FDA, or because it was discontinued by the labeler. Possible values in this field are: "D", "E", "I", "N", "U".