NDC 63629-2038 Urea

Urea

NDC Product Code 63629-2038

NDC CODE: 63629-2038

Proprietary Name: Urea 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.

Non-Proprietary Name: Urea 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.

Drug Use Information

Drug Use Information
The drug use information is a summary and does NOT have all possible information about this product. This information does not assure that this product is safe, effective, or appropriate. This information is not individual medical advice and does not substitute for the advice of a health care professional. Always ask a health care professional for complete information about this product and your specific health needs.

  • Urea is used to treat dry/rough skin conditions (e.g., eczema, psoriasis, corns, callus) and some nail problems (e.g., ingrown nails). It may also be used to help remove dead tissue in some wounds to help wound healing. Urea is known as a keratolytic. It increases moisture in the skin by softening/dissolving the horny substance (keratin) holding the top layer of skin cells together. This effect helps the dead skin cells fall off and helps the skin keep more water in.

NDC Code Structure

  • 63629 - Bryant Ranch Prepack

NDC 63629-2038-1

Package Description: 85 g in 1 BOTTLE

NDC Product Information

Urea with NDC 63629-2038 is a a human prescription drug product labeled by Bryant Ranch Prepack. The generic name of Urea is urea. The product's dosage form is cream and is administered via topical form.

Labeler Name: Bryant Ranch Prepack

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.

Product Type: Human Prescription Drug 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.

Urea Active Ingredient(s)

What is the Active Ingredient(s) List?
This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted.

  • UREA 40 g/100g

Inactive Ingredient(s)

About the Inactive Ingredient(s)
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.

  • WATER (UNII: 059QF0KO0R)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • MINERAL OIL (UNII: T5L8T28FGP)
  • CETYL ALCOHOL (UNII: 936JST6JCN)
  • CARBOMER HOMOPOLYMER TYPE A (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: F68VH75CJC)
  • PETROLATUM (UNII: 4T6H12BN9U)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • SODIUM HYDROXIDE (UNII: 55X04QC32I)

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.

Labeler Name: Bryant Ranch Prepack
Labeler Code: 63629
Marketing Category: UNAPPROVED DRUG OTHER - 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: 09-01-2014 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: 12-31-2022 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: N 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. Values = ‘Y’ or ‘N’.

* Please review the disclaimer below.

Urea Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Product Labeling Index

Description

Rx OnlyFor external use only. Not for ophthalmic use.DescriptionUrea 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

NDC: 63629-2038-1 85 grams Cream 40% in a BOTTLE, PLASTIC

* Please review the disclaimer below.