NDC 82429-119 Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides
Iodoquinol, Hydrocortisone Acetate, And Aloe Vera Leaf Gel Topical

Product Information

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, RxNorm crosswalk and the complete product label.

NDC Product Code82429-119
Proprietary Name What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides
Non-Proprietary Name 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.
Iodoquinol, Hydrocortisone Acetate, And Aloe Vera Leaf
Product Type 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.
Human Prescription Drug
Dosage FormGel - 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) What are the Administration Route(s)?
The translation of the route code submitted by the firm, indicating route of administration.
  • Topical - Administration to a particular spot on the outer surface of the body. The E2B term TRANSMAMMARY is a subset of the term TOPICAL.
Product Labeler Information What is the Labeler Name?
Name of Company corresponding to the labeler code segment of the Product NDC.
Gabar Health Sciences Corp.
Labeler Code82429
Marketing Category 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.
Start Marketing Date What is the Start Marketing Date?
This is the date that the labeler indicates was the start of its marketing of the drug product.
Listing Expiration Date 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.
Exclude Flag 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".
NDC Code Structure

What are the uses for Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides?

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 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.

Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides Active Ingredients UNII Codes

NDC to RxNorm Crosswalk

What is RxNorm? 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

Pharmacologic Class(es)

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.

Iodoquinol Hydrocortisone Acetate Aloe Polysaccharides Product Label

FDA filings in the form of structured product labels are documents that include all published material associated whith this product. Product label information includes data like indications and usage generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Label Table of Contents


Rx Only

Manufactured for and distributed by:

Gabar Health Sciences Corp.1 Hartsfield Center Parkway
Atlanta GA 30354

Gabar Health Sciences Corp

Rev 02/2023


Each gram contains 20 mg of hydrocortisone acetate, 10 mg of iodoquinol and 10 mg of aloe polysaccharide in a vehicle consisting of: aminomethyl propanol, benzyl alcohol, blue 1, carbomer, glycerin, magnesium aluminum silicate, palmitoyl tripeptide-5, PPG-20 methyl glucose ether, purified water, propylene glycol, SD Alcohol 40B, yellow 10.

Hydrocortisone acetate is an anti-inflammatory and antipruritic agent. Chemically, hydrocortisone acetate is [Pregn-4-ene-3, 20-dione, 21-(acetyloxy)-11, 17-dihydroxy-, (11-β)-] with the molecular formula (C 23H 32O 6) and is represented by the following structural formula:

Iodoquinol is an antifungal and antibacterial agent. Chemically, Iodoquinol is [5,7-diiodo-8-quinolinol] with the molecular formula (C 9H 5I 2NO) and is represented by the following structural formula:

Aloe Polysaccharides are a concentrated, water soluble subcomponent of Aloe Vera with a mono-sugar ratio of Man : Gal : Glc: 40 : 1.4 : 1.0, linkage of 1-4 ß - linkage, O-Acetyl group of 25% of sugar units, and specific rotation of [α] D= -3.98° at 23.2° C. Average molecular weight is 80,000 daltons. Chemically, Aloe Polysaccharides is represented by the following structural formula:

Clinical Pharmacology

Hydrocortisone acetate has anti-inflammatory, antipruritic and vasoconstrictive properties. While the mechanism of anti-inflammatory activity is unclear, there is evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in humans. Iodoquinol has both antifungal and antibacterial properties.


The extent of percutaneous absorption of topical steroids is determined by many factors including the vehicle, the integrity of the epidermal barrier and the use of occlusive dressings. Hydrocortisone acetate can be absorbed from normal intact skin. Inflammation and/or other inflammatory disease processes in the skin increase percutaneous absorption. Occlusive dressings substantially increase the percutaneous absorption of topical corticosteroids. Once absorbed through the skin, hydrocortisone acetate is metabolized in the liver and most body tissue to hydrogenated and degraded forms such as tetrahydrocortisone and tetrahydrocortisol. These are excreted in the urine, mainly conjugated as glucuronides, together with a very small proportion of unchanged hydrocortisone acetate. There are no data available regarding the percutaneous absorption of iodoquinol; however, following oral administration, 3-5% of the dose was recovered in the urine as a glucuronide.


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.


This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.




FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. Avoid contact with eyes, lips and mucous membranes.

Information For Patients

If irritation develops, the use of this product should be discontinued and appropriate therapy instituted. Staining of the skin, hair and fabrics may occur. Not intended for use on infants or under diapers or occlusive dressings. If extensive areas are treated or if the occlusive dressing technique is used, the possibility exists of increased systemic absorption of the corticosteroid, and suitable precautions should be taken. Children may absorb proportionally larger amounts of topical corticosteroids and thus be more susceptible to systemic toxicity. Parents of pediatric patients should be advised not to use tight-fitting diapers or plastic pants on a child being treated in the diaper area, as these garments may constitute occlusive dressings.

Iodoquinol may be absorbed through the skin and interfere with thyroid function tests. If such tests are contemplated, wait at least one month after discontinuance of therapy to perform these tests. The ferric chloride test for phenylketonuria (PKU) can yield a false positive result if iodoquinol is present in the diaper or urine. Prolonged use may result in overgrowth of non-susceptible organisms requiring appropriate therapy. Burning, itching, irritation and dryness have been reported infrequently following the use of topical corticosteroids.

Carcinogenesis, Mutagenesis And Impairment Of Fertility

Long-term animal studies for carcinogenic potential have not been performed on this product to date. In vitro studies to determine mutagenicity with hydrocortisone have revealed negative results. Mutagenicity studies have not been performed with iodoquinol.

Category C

Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

Pediatric Use

Safety and effectiveness in pediatric patients under the age of 12 have not been established.

Adverse Reactions

The following local adverse reactions are reported infrequently with topical corticosteroids. These reactions are listed in an approximate decreasing order of occurrence: burning, itching, irritation, dryness, folliculitis, hypertrichosis, acneiform eruptions, hypopigmentation, perioral dermatitis, allergic contact dermatitis, maceration of the skin, secondary infections, skin atrophy, striae and miliaria.

Dosage And Administration

Apply to affected area(s) three to four times per day or as directed by a physician. Follow your physician's directions regarding length of treatment after symptoms resolve.


Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.

NOTICE: Protect from freezing and excessive heat.

How Supplied

This product is supplied in the following size(s):

48 g Tube, NDC 82429-119-48

Call your doctor about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Principal Display Panel - 48 G Tube Carton

Gabar Health Sciences Corp.

NDC 82429-119-48

Iodoquinol 1%-Hydrocortisone Acetate 2%

Aloe Polysaccharides 1% Gel

Net Wt. 48 g (1.69 oz.)

Rx Only

For external use only.

Not for ophthalmic use.

* Please review the disclaimer below.