NDC 71399-4528 Urea

Urea

NDC Product Code 71399-4528

NDC 71399-4528-1

Package Description: 1 BOTTLE, GLASS in 1 CARTON > 28 mL in 1 BOTTLE, GLASS

NDC Product Information

Urea with NDC 71399-4528 is a a human prescription drug product labeled by Akron Pharma Inc. The generic name of Urea is urea. The product's dosage form is gel and is administered via topical form.

Labeler Name: Akron Pharma Inc

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.

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 .45 mg/mL

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.

  • CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
  • EDETATE SODIUM (UNII: MP1J8420LU)
  • EUCALYPTUS OIL (UNII: 2R04ONI662)
  • HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)
  • MENTHOL (UNII: L7T10EIP3A)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • WATER (UNII: 059QF0KO0R)

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: Akron Pharma Inc
Labeler Code: 71399
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: 03-22-2019 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: 12-31-2020 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

DESCRIPTION: UREA Nail Gel 45% is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of UREA Nail Gel 45% contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, propylene glycol and purified water.UREA is a diamide of carbonic acid with the following chemical structure:

Clinical Pharmacology

CLINICAL PHARMACOLOGY: Urea gently dissolves the intracellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

Pharmacokinetics

PHARMACOKINETICS: The mechanism of action of topically applied Urea is not yet known.

Indications & Usage

INDICATIONS AND USES: 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, keratoderma, corns and calluses, as well as damaged and ingrown nails.

Contraindications

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

Warnings

WARNINGS: For external use only. Avoid contact with eyes, lips or mucous membranes.

Precautions

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. KEEP THIS AND ALL MEDICATIONS OUT OF REACH OF CHILDREN.PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Urea Nail Gel 45% should be given to a pregnant woman only if clearly needed.NURSING MOTHERS: It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Urea Nail Gel 45% is administered to a nursing woman.

Adverse Reactions

ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.Call your doctor for medical advice about side effects.

Dosage & Administration

DOSAGE AND ADMINISTRATION: Apply Urea Nail Gel 45% to diseased or damaged nail tissue twice per day, or as directed by a physician.DIRECTIONS FOR SKIN: Apply Urea Nail Gel 45% to affected area(s) twice per day, or as directed by a physician. Rub in until gel is absorbed.

How Supplied

HOW SUPPLIED:Urea Nail Gel 45% is supplied in a 28 mL glass bottle NDC 71399-4528-1.Store at controlled room temperature 15 to 30°C (59 to 86°F). Protect from freezing.Manufactured in the U.S.A. for Akron pharma Inc. Fairfield, NJ 07004REV 03/19

* Please review the disclaimer below.

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