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  4. NDC Product Code: 83566-068 Gze Black Hair Dyeshampoo

NDC 83566-068 Gze Black Hair Dyeshampoo

Resorcinol Cream Topical - View Dosage, Usage, Ingredients, Routes, UNII

Table of Contents

  1. Product Information
  2. Product Packages
  3. What is NDC 83566-068?
  4. Gze Black Hair Dyeshampoo Uses
  5. Active Ingredients
  6. Active Ingredients UNII Codes
  7. Inactive Ingredients UNII Codes

Product Information

NDC Product Code:
83566-068
Proprietary Name:
Gze Black Hair Dyeshampoo
Non-Proprietary Name: [1]
Resorcinol
Substance Name: [2]
Manchurian Walnut Shell; Resorcinol; Stearamidoethyl Ethanolamine Monophosphate; Thuja Occidentalis Leaf
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]
    Guangzhou Yilong Cosmetics Co., Ltd
    Labeler Code:
    83566
    Product Label ID:
    1b117713-db3a-7f2a-e063-6394a90a5bc8
    FDA Application Number: [6]
    505G(a)(3)
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    10-20-2023
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
    Code Navigator:

    Code Structure Chart

    Product Details

    What is NDC 83566-068?

    The NDC code 83566-068 is assigned by the FDA to the product Gze Black Hair Dyeshampoo which is a human over the counter drug product labeled by Guangzhou Yilong Cosmetics Co., Ltd. The generic name of Gze Black Hair Dyeshampoo is resorcinol. 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 83566-068-01 500 ml in 1 bottle, pump . 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 Gze Black Hair Dyeshampoo?

    Skin test before using; Keep hair dry, wear the gloves; Apply on wet hair and avoid touching your for ehead, wash with water after 20 minutes.

    What are Gze Black Hair Dyeshampoo 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 Gze Black Hair Dyeshampoo UNII Codes?

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

    • RESORCINOL (UNII: YUL4LO94HK)
    • RESORCINOL (UNII: YUL4LO94HK) (Active Moiety)
    • STEARAMIDOETHYL ETHANOLAMINE MONOPHOSPHATE (UNII: A3JOC2G06K)
    • STEARAMIDOETHYL ETHANOLAMINE MONOPHOSPHATE (UNII: A3JOC2G06K) (Active Moiety)
    • THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786)
    • THUJA OCCIDENTALIS LEAF (UNII: 0T0DQN8786) (Active Moiety)
    • MANCHURIAN WALNUT SHELL (UNII: 98BYA5WZQQ)
    • MANCHURIAN WALNUT SHELL (UNII: 98BYA5WZQQ) (Active Moiety)

    Which are Gze Black Hair Dyeshampoo 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.

    [6] What is the FDA Application Number? - This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

    [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".