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  4. NDC Product Code: 83364-001 Ariella Nail Repair Pen

NDC 83364-001 Ariella Nail Repair Pen

Poliglusam,Salicylic Acid Liquid Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 83364-001?
  4. Ariella Nail Repair Pen Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
83364-001
Proprietary Name:
Ariella Nail Repair Pen
Non-Proprietary Name: [1]
Poliglusam, Salicylic Acid
Substance Name: [2]
Poliglusam; Salicylic Acid
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]
    Yitongbada (shenzhen) International Trade Co., Ltd
    Labeler Code:
    83364
    Product Label ID:
    069c1bf6-9df0-4e86-9928-f81cb59244c3
    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]
    05-12-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 83364-001?

    The NDC code 83364-001 is assigned by the FDA to the product Ariella Nail Repair Pen which is a human over the counter drug product labeled by Yitongbada (shenzhen) International Trade Co., Ltd. The generic name of Ariella Nail Repair Pen is poliglusam, salicylic acid. The product's dosage form is liquid and is administered via topical form. The product is distributed in 2 packages with assigned NDC codes 83364-001-01 2 tube in 1 box / 3 ml in 1 tube, 83364-001-02 4 tube in 1 box / 3 ml in 1 tube. 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 Ariella Nail Repair Pen?

    Soak your feet in hot water for 5 minutes, then dry your toes.Use a nail cutter and file (not included) to trim nails that need repair so that the liquid can soak in better.Gently turn the end of the pen to dispense treatment liquid onto the brush applicator.Apply the liquid over the areas that need to be repaired, and make sure to cover all affected parts.Use daily for 2-4 weeks, according to the condition of the area that needs repair.Recommended use: 2-3 times a day.

    What are Ariella Nail Repair Pen 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.
    • POLIGLUSAM 2 g/100mL - Deacetylated CHITIN, a linear polysaccharide of deacetylated beta-1,4-D-glucosamine. It is used in HYDROGEL and to treat WOUNDS.
    • SALICYLIC ACID 3 g/100mL - A compound obtained from the bark of the white willow and wintergreen leaves. It has bacteriostatic, fungicidal, and keratolytic actions.

    Which are Ariella Nail Repair Pen UNII Codes?

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

    Which are Ariella Nail Repair Pen 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".