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  4. NDC Product Code: 83364-003 Fungifree Antifungal Ringworm Cream

NDC 83364-003 Fungifree Antifungal Ringworm Cream

Menthol, Colloidal Silver, Miconazole Cream Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 83364-003?
  4. Fungifree Antifungal Ringworm Cream Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes
  8. Pharmacologic Classes

Product Information

NDC Product Code:
83364-003
Proprietary Name:
Fungifree Antifungal Ringworm Cream
Non-Proprietary Name: [1]
Menthol, Colloidal Silver, Miconazole
Substance Name: [2]
Menthol, Unspecified Form; Miconazole; Silver
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Cream - An emulsion, semisolid3 dosage form, usually containing > 20% water and volatiles5 and/or < 50% hydrocarbons, waxes, or polyols as the vehicle. This dosage form is generally for external application to the skin or mucous membranes.
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:
    a8c848e2-1be3-4fc6-8f3b-80aa3db990e6
    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]
    02-25-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
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    Code Structure Chart

    Product Details

    What is NDC 83364-003?

    The NDC code 83364-003 is assigned by the FDA to the product Fungifree Antifungal Ringworm Cream which is a human over the counter drug product labeled by Yitongbada (shenzhen) International Trade Co., Ltd. The generic name of Fungifree Antifungal Ringworm Cream is menthol, colloidal silver, miconazole. The product's dosage form is cream and is administered via topical form. The product is distributed in a single package with assigned NDC code 83364-003-01 1 jar in 1 box / 50 g in 1 jar. 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 Fungifree Antifungal Ringworm Cream?

    Clean and dry the affected area.Apply a thin layer of cream 3-4 times daily.Use daily for 4 weeks.If your condition persists, see a doctor.This product is not effective on the scalp or nails. Avoid applying it to the face.

    What are Fungifree Antifungal Ringworm Cream 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.
    • MENTHOL, UNSPECIFIED FORM 8 g/100g
    • MICONAZOLE .1 g/100g - An imidazole antifungal agent that is used topically and by intravenous infusion.
    • SILVER .1 g/100g - An element with the atomic symbol Ag, atomic number 47, and atomic weight 107.87. It is a soft metal that is used medically in surgical instruments, dental prostheses, and alloys. Long-continued use of silver salts can lead to a form of poisoning known as ARGYRIA.

    Which are Fungifree Antifungal Ringworm Cream UNII Codes?

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

    Which are Fungifree Antifungal Ringworm Cream 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:

    Which are the Pharmacologic Classes for Fungifree Antifungal Ringworm Cream?

    A pharmacologic class is a group of drugs that share the same scientifically documented properties. The following is a list of the reported pharmacologic class(es) corresponding to the active ingredients of this product.

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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".