Urea 41%
Urea
Puretek Corporation
Human Prescription Drug
NDC 59088-489Urea 41% also known as Urea is a human prescription drug labeled by 'Puretek Corporation'. National Drug Code (NDC) number for Urea 41% is 59088-489. This drug is available in dosage form of Cream. The names of the active, medicinal ingredients in Urea 41% drug includes Urea - 410 mg/g . The currest status of Urea 41% drug is Active.
Drug Information:
| Drug NDC: | 59088-489 |
| 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 41% |
| 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: | Puretek Corporation |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Cream |
| 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 - 410 mg/g
|
| 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: | 07 Jun, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 23 Dec, 2025 |
| 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, 2023 |
| 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: | PureTek Corporation
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 1436933
|
| The RxNorm Concept Unique Identifier. RxCUI is a unique number that describes a semantic concept about the drug product, including its ingredients, strength, and dose forms. |
| Original Packager: | Yes
|
| Whether or not the drug has been repackaged for distribution. |
| UNII: | 8W8T17847W
|
| 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 |
|---|
| 59088-489-16 | 227 g in 1 BOTTLE (59088-489-16) | 07 Jun, 2022 | 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 41% urea ceteareth-25 ceteareth-6 cetyl alcohol methylparaben paraffin propylene glycol water stearyl alcohol xanthan gum urea urea
Indications and Usage:
Indications & usage for debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, ï¬brinous or purulent debris or eshar. 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.
Warnings:
Warnings for external use only. not for ophthalmic use. keep out of reach of children. avoid contact with eyes, lips and mucous membranes. general this product 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. information for patients patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. avoid contact with eyes, lips and mucous membranes. carcinogenesis, mutagenesis and impairment of fertility: long-term animal studies for carcinogenic potential have not been performed on this product to date. studies on reproduction and fertility also have not been performed. pregnancy: 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 h
Read more...arm 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.
General Precautions:
General this product 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.
Dosage and Administration:
Dosage and administration apply urea 41% 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.
Contraindications:
Contraindications this product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Adverse Reactions:
Adverse reactions: transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.
Use in Pregnancy:
Pregnancy: 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.
Description:
Description urea 41% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. each gram contains 410 mg of urea in a vehicle consisting of: aqua (purified water), ceteareth-6, ceteareth-25, cetyl alcohol, methylparaben, paraffin, propylene glycol, stearyl alcohol, xanthan gum. urea is a diamide of carbonic acid with the following chemical structure: chemical structure
Clinical Pharmacology:
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.
Pharmacokinetics:
Pharmacokinetics the mechanism of action of topically applied urea is not yet known.
Carcinogenesis and Mutagenesis and Impairment of Fertility:
Carcinogenesis, mutagenesis and impairment of fertility: long-term animal studies for carcinogenic potential have not been performed on this product to date. studies on reproduction and fertility also have not been performed.
How Supplied:
How supplied urea 41% cream 8 oz. (227 g): ndc 59088-489-16
Information for Patients:
Information for patients patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. avoid contact with eyes, lips and mucous membranes.
Package Label Principal Display Panel:
Urea 41% cream⢠manufactured in the usa by: puretek corporation panorama city, ca 91402 for questions or information call toll-free: 877-921-7873 label