NDC 82429-308 Urea 40%
Urea Cream Topical

Product Information

What is NDC 82429-308?

The NDC code 82429-308 is assigned by the FDA to the product Urea 40% which is a human prescription drug product labeled by Gabar Health Sciences Corp.. The generic name of Urea 40% is urea. The product's dosage form is cream and is administered via topical form. The product is distributed in 3 packages with assigned NDC codes 82429-308-15 1 bottle, plastic in 1 carton / 28 g in 1 bottle, plastic, 82429-308-24 1 bottle, plastic in 1 carton / 85 g in 1 bottle, plastic, 82429-308-25 1 bottle, plastic in 1 carton / 198 g in 1 bottle, plastic. 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 Code82429-308
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.
Urea 40%
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.
Urea
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 FormCream - 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) 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.
UNAPPROVED DRUG OTHER -
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.
10-10-2022
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.
12-31-2023
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".
N
NDC Code Structure

What are the uses for Urea 40%?


Product Characteristics

Color(s)WHITE (C48325)

Product Packages

NDC Code 82429-308-15

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 28 g in 1 BOTTLE, PLASTIC

NDC Code 82429-308-24

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 85 g in 1 BOTTLE, PLASTIC

NDC Code 82429-308-25

Package Description: 1 BOTTLE, PLASTIC in 1 CARTON / 198 g in 1 BOTTLE, PLASTIC

Product Details

What are Urea 40% 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.
  • UREA 40 g/100g - A compound formed in the liver from ammonia produced by the deamination of amino acids. It is the principal end product of protein catabolism and constitutes about one half of the total urinary solids.

Urea 40% 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:

Urea 40% 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.

* Please review the disclaimer below.

Urea 40% 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



Description



Rx Only

For external use only. Not for ophthalmic use.

Description

Urea 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 40% contains 40% urea as an active ingredient, and the following inactive ingredients: Water, Propylene Glycol, Glyceryl Stearate, Mineral Oil, Cetyl Alcohol, Carbomer, Petrolatum, Xanthan Gum and Sodium Hydroxide.

Urea is a diamide of carbonic acid with the following chemical structure:


Clinical Pharmacology



Urea gently dissolves the intracellular matrix which results in loosening of the horny layer of the skin and shedding of scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.


Pharmacokinetics



The mechanism of action of topically applied urea is not yet known.


Indications And Usage



For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.


Contraindications



Known hypersensitivity to any of the listed ingredients.


Warnings



For topical use only. Avoid contact with eyes, lips or mucous membranes.


Precautions



This medication is to be used as directed by a physician and should not be used to treat any condition other than that, for which it was prescribed. If redness or irritation occurs, discontinue use, and consult a physician.


Adverse Reactions



Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.


Dosage And Administration



Apply Urea 40% to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed.
Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.


How Supplied



Urea 40% Cream 1 oz. (28.35 g): NDC 82429-308-15
Urea 40% Cream 3 oz. (85 g): NDC 82429-308-24
Urea 40% Cream 7 oz. (198.4 g): NDC 82429-308-25

Store at room temperature 15°C - 30°C (59°F-86°F). Protect from freezing. Keep bottle tightly closed.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

Manufactured for and distributed by:
Gabar Health Sciences Corp.
Atlanta, GA 30354


* Please review the disclaimer below.