NDC 84128-003 Surgical Scrub Brush/sponge With Nail Cleaner 4% Chg

Chlorhexidine Gluconate Sponge Cutaneous - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
84128-003
Proprietary Name:
Surgical Scrub Brush/sponge With Nail Cleaner 4% Chg
Non-Proprietary Name: [1]
Chlorhexidine Gluconate
Substance Name: [2]
Chlorhexidine Gluconate
NDC Directory Status:
Human Otc Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Sponge - A porous, interlacing, absorbent material that contains a drug. It is typically used for applying or introducing medication, or for cleansing. A sponge usually retains its shape.
Administration Route(s): [4]
  • Cutaneous - Administration to the skin.
  • Labeler Code:
    84128
    FDA Application Number: [6]
    M003
    Marketing Category: [8]
    OTC MONOGRAPH DRUG -
    Start Marketing Date: [9]
    02-27-2024
    Listing Expiration Date: [11]
    12-31-2025
    Exclude Flag: [12]
    N
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    Product Details

    What is NDC 84128-003?

    The NDC code 84128-003 is assigned by the FDA to the product Surgical Scrub Brush/sponge With Nail Cleaner 4% Chg which is a human over the counter drug product labeled by Xinxiang Xinda Technology Co.,ltd. The generic name of Surgical Scrub Brush/sponge With Nail Cleaner 4% Chg is chlorhexidine gluconate. The product's dosage form is sponge and is administered via cutaneous form. The product is distributed in a single package with assigned NDC code 84128-003-01 30 bag in 1 box / 1 patch in 1 bag / 20 ml in 1 patch. 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 Surgical Scrub Brush/sponge With Nail Cleaner 4% Chg?

    This medication is used along with regular tooth brushing/flossing to treat gingivitis, a gum disease that causes red, swollen, and easily bleeding gums. Chlorhexidine belongs to a class of drugs known as antimicrobials. It works by decreasing the amount of bacteria in the mouth, helping to reduce swelling and redness of the gums and bleeding when you brush.

    What are Surgical Scrub Brush/sponge With Nail Cleaner 4% Chg 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 Surgical Scrub Brush/sponge With Nail Cleaner 4% Chg UNII Codes?

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

    Which are Surgical Scrub Brush/sponge With Nail Cleaner 4% Chg 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:

    What is the NDC to RxNorm Crosswalk for Surgical Scrub Brush/sponge With Nail Cleaner 4% Chg?

    RxNorm is a normalized naming system for generic and branded drugs that assigns unique concept identifier(s) known as RxCUIs to NDC products.The NDC to RxNorm Crosswalk for this produdct indicates multiple concept unique identifiers (RXCUIs) are associated with this product:
    • RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Liquid Soap
    • RxCUI: 211365 - chlorhexidine gluconate 40 MG/ML Medicated Liquid Soap
    • RxCUI: 211365 - chlorhexidine gluconate 4 % Medicated Surgical Scrub

    Which are the Pharmacologic Classes for Surgical Scrub Brush/sponge With Nail Cleaner 4% Chg?

    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.

    * Please review the disclaimer below.

    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".