NDC 82429-119 Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides

Iodoquinol,Hydrocortisone Acetate,And Aloe Vera Leaf Gel Topical - View Dosage, Usage, Ingredients, Routes, UNII

Product Information

NDC Product Code:
82429-119
Proprietary Name:
Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides
Non-Proprietary Name: [1]
Iodoquinol, Hydrocortisone Acetate, And Aloe Vera Leaf
Substance Name: [2]
Aloe Vera Leaf; Hydrocortisone Acetate; Iodoquinol
NDC Directory Status:
Human Prescription Drug
Product Type: [3]
ACTIVE PRODUCT INCLUDED in the NDC Directory
Dosage Form:
Gel - A semisolid3 dosage form that contains a gelling agent to provide stiffness to a solution or a colloidal dispersion.4 A gel may contain suspended particles.
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]
    Gabar Health Sciences Corp.
    Labeler Code:
    82429
    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]
    02-24-2023
    Listing Expiration Date: [11]
    12-31-2024
    Exclude Flag: [12]
    N
    Code Structure:
    Code Navigator:

    Product Characteristics

    Color(s):
    GREEN (C48329)

    Product Packages

    NDC Code 82429-119-48

    Package Description: 1 TUBE in 1 CARTON / 48 g in 1 TUBE

    Product Details

    What is NDC 82429-119?

    The NDC code 82429-119 is assigned by the FDA to the product Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides which is a human prescription drug product labeled by Gabar Health Sciences Corp.. The generic name of Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides is iodoquinol, hydrocortisone acetate, and aloe vera leaf. The product's dosage form is gel and is administered via topical form. The product is distributed in a single package with assigned NDC code 82429-119-48 1 tube in 1 carton / 48 g 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 Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides?

    Based on a review of a related drug by the National Research Council and subsequent FDA classification for that drug, the indications are as follows: "Possibly" Effective: Contact or atopic dermatitis; impetiginized eczema; nummular eczema; endogenous chronic infectious dermatitis; stasis dermatitis; pyoderma; nuchal eczema and chronic eczematoid otitis externa; acne urticata; localized or disseminated neurodermatitis; lichen simplex chronicus; anogenital pruritus (vulvae, scroti, ani); folliculitis; bacterial dermatoses; mycotic dermatoses such as tinea (capitis, cruris, corporis, pedis); monliasis; intertrigo. Final classification of the less-than-effective indications requires further investigation.

    What are Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides 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 Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides UNII Codes?

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

    What is the NDC to RxNorm Crosswalk for Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides?

    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: 1191376 - iodoquinol 1 % / hydrocortisone acetate 2 % / aloe polysaccharides 1 % Topical Gel
    • RxCUI: 1191376 - aloe polysaccharide 0.01 MG/MG / hydrocortisone acetate 0.02 MG/MG / iodoquinol 0.01 MG/MG Topical Gel
    • RxCUI: 1191376 - aloe polysaccharides 1 % / hydrocortisone acetate 2 % / iodoquinol 1 % Topical Gel

    Which are the Pharmacologic Classes for Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides?

    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.

    [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".