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NDC 80851-403 Droxyd 3.98

Chitosan Liquid Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 80851-403?
  4. Droxyd 3.98 Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
80851-403
Proprietary Name:
Droxyd 3.98
Non-Proprietary Name: [1]
Chitosan
Substance Name: [2]
Chitosan Medium Molecular Weight (200-400 Mpa.s)
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Liquid - A dosage form consisting of a pure chemical in its liquid1 state. This dosage form term should not be applied to solutions.
Administration Route(s): [4]
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
    • Labeler Name: [5]
    Oxytical
    Labeler Code:
    80851
    Product Label ID:
    0d90b69d-5068-5af2-e063-6294a90a693c
    Marketing Category: [8]
    UNAPPROVED DRUG OTHER - An unapproved drug product in a marketing category that is not reflected on a particular list.
    Start Marketing Date: [9]
    11-12-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Code Structure Chart

    Product Details

    What is NDC 80851-403?

    The NDC code 80851-403 is assigned by the FDA to the product Droxyd 3.98 which is a human over the counter drug product labeled by Oxytical. The generic name of Droxyd 3.98 is chitosan. The product's dosage form is liquid and is administered via topical form. The product is distributed in a single package with assigned NDC code 80851-403-01 20 ml in 1 bottle, glass . This page includes all the important details about this product, including active and inactive ingredients, pharmagologic classes, product uses and characteristics, UNII information and RxNorm crosswalk.

    What are the uses for Droxyd 3.98?

    [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.

    What are Droxyd 3.98 Active Ingredients?

    An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    Which are Droxyd 3.98 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 Droxyd 3.98 Inactive Ingredients 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 Footnotes

    [1] What is the Non-Proprietary Name? - The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.

    [2] What is the Substance Name? - An active ingredient is the substance responsible for the medicinal effects of a product specified by the substance's molecular structure or if the molecular structure is not known, defined by an unambiguous definition that identifies the substance. Each active ingredient name is the preferred term of the UNII code submitted.

    [3] What kind of product is this? - Indicates the type of product, such as Human Prescription Drug or Human Over the Counter Drug. This data element matches the “Document Type” field of the Structured Product Listing.

    [4] What are the Administration Routes? - The translation of the route code submitted by the firm, indicating route of administration.

    [5] What is the Labeler Name? - Name of Company corresponding to the labeler code segment of the Product NDC.

    [8] 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.

    [9] What is the Start Marketing Date? - This is the date that the labeler indicates was the start of its marketing of the drug product.

    [11] 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.

    [12] 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 ("Y"), or because the listing certification is expired ("E"), or because the listing data was inactivated by FDA ("I"). Values = "Y", "N", "E", or "I".