Urea
Exact-rx, Inc.
Human Prescription Drug
NDC 42808-204Urea is a human prescription drug labeled by 'Exact-rx, Inc.'. National Drug Code (NDC) number for Urea is 42808-204. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Urea drug includes Urea - 450 mg/mL . The currest status of Urea drug is Active.
Drug Information:
| Drug NDC: | 42808-204 |
| The labeler code and product code segments of the National Drug Code number, separated by a hyphen. Asterisks are no longer used or included within the product code segment to indicate certain configurations of the NDC. |
| Proprietary Name: | Urea |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Prescription Drug |
| Indicates the type of product, such as Human Prescription Drug or Human OTC Drug. This data element corresponds to the “Document Type” of the SPL submission for the listing. |
| Non Proprietary Name: | Urea |
| Also known as the generic name, this is usually the active ingredient(s) of the product. |
| Labeler Name: | Exact-rx, Inc. |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Gel |
| The translation of the DosageForm Code submitted by the firm. There is no standard, but values may include terms like `tablet` or `solution for injection`.The complete list of codes and translations can be found www.fda.gov/edrls under Structured Product Labeling Resources. |
| Status: | Active |
| FDA does not review and approve unfinished products. Therefore, all products in this file are considered unapproved. |
| Substance Name: | UREA - 450 mg/mL
|
| This is the active ingredient list. Each ingredient name is the preferred term of the UNII code submitted. |
| Route Details: | TOPICAL
|
| The translation of the Route Code submitted by the firm, indicating route of administration. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources. |
Marketing Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Marketing Category: | UNAPPROVED DRUG OTHER |
| Product types are broken down into several potential Marketing Categories, such as New Drug Application (NDA), Abbreviated New Drug Application (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. |
| Marketing Start Date: | 01 Aug, 2011 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 18 Jun, 2026 |
| This is the date the product will no longer be available on the market. If a product is no longer being manufactured, in most cases, the FDA recommends firms use the expiration date of the last lot produced as the EndMarketingDate, to reflect the potential for drug product to remain available after manufacturing has ceased. Products that are the subject of ongoing manufacturing will not ordinarily have any EndMarketingDate. Products with a value in the EndMarketingDate will be removed from the NDC Directory when the EndMarketingDate is reached. |
| Listing Expiration Date: | 31 Dec, 2024 |
| This is the date when the listing record will expire if not updated or certified by the firm. |
OpenFDA Information:
An openfda section: An annotation with additional product identifiers, such as NUII and UPC, of the drug product, if available.
| Manufacturer Name: | |
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| UNII: | |
| Unique Ingredient Identifier, which is a non-proprietary, free, unique, unambiguous, non-semantic, alphanumeric identifier based on a substance’s molecular structure and/or descriptive information. |
Packaging Information:
| Package NDC | Description | Marketing Start Date | Marketing End Date | Sample Available |
|---|
| 42808-204-28 | 1 BOTTLE, GLASS in 1 CARTON (42808-204-28) / 28 mL in 1 BOTTLE, GLASS | 01 Aug, 2011 | N/A | No |
| Package NDC number, known as the NDC, identifies the labeler, product, and trade package size. The first segment, the labeler code, is assigned by the FDA. Description tells the size and type of packaging in sentence form. Multilevel packages will have the descriptions concatenated together. |
Product Elements:
Urea urea camphor (synthetic) edetate disodium eucalyptus oil hydroxyethyl cellulose (2000 cps at 1%) menthol propylene glycol water urea urea
Indications and 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.
Warnings:
Warnings: for external use only. avoid contact with eyes, lips or mucous membranes.
Dosage and Administration:
Dosage and administration: apply urea nail gel 45% to diseased or damaged nail tissue twice per day, or as directed by a physician.
Contraindications:
Contraindications: known hypersensitivity to any of the listed ingredients.
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.
Use in Pregnancy:
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.
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: 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.
How Supplied:
How supplied: urea nail gel 45% is supplied in a 28 ml glass bottle ndc 42808-0204-28. store at controlled room temperature 15 to 30°c (59 to 86°f). protect from freezing. manufactured in the u.s.a. for exact-rx, inc., melville, ny 11747 00-0204-28-205-00 iss:7/11
Package Label Principal Display Panel:
Principal display panel for external use only ndc 42808-0204-28 rx only urea in a vehicle containing menthol, camphor & eucalyptus oil 45% nail gel exact-rx. incorporated net wt. 28 ml carton