Urea 20
Urea
Avpak
Human Otc Drug
NDC 50268-820Urea 20 also known as Urea is a human otc drug labeled by 'Avpak'. National Drug Code (NDC) number for Urea 20 is 50268-820. This drug is available in dosage form of Gel. The names of the active, medicinal ingredients in Urea 20 drug includes Urea - 200 mg/g . The currest status of Urea 20 drug is Active.
Drug Information:
| Drug NDC: | 50268-820 |
| 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 20 |
| Also known as the trade name. It is the name of the product chosen by the labeler. |
| Product Type: | Human Otc 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: | Avpak |
| 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 - 200 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: | 19 Sep, 2022 |
| This is the date that the labeler indicates was the start of its marketing of the drug product. |
| Marketing End Date: | 24 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: | AvPAK
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| 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 |
|---|
| 50268-820-85 | 1 TUBE in 1 CARTON (50268-820-85) / 85 g in 1 TUBE | 19 Sep, 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. |
Purpose:
Purpose : moisturizer
Product Elements:
Urea 20 urea cetyl alcohol carbomer homopolymer, unspecified type glycerin glyceryl stearate se mineral oil water stearyl alcohol triacetin white petrolatum urea urea opaque white
Indications and Usage:
Usage: soothes, softens and moisturizes dry rough skin.
Warnings:
Warnings section caution: do not apply to broken skin. if redness occurs, discontinue use. avoid contact with eyes.
Do Not Use:
Warnings section caution: do not apply to broken skin. if redness occurs, discontinue use. avoid contact with eyes.
When Using:
Directions: apply to desired areas of the hands, feet, knees, or elbows twice daily, or as directed by a physician. rub into the skin until fully absorbed. do not use on tender skin areas such as the face, neck, or scalp.
Dosage and Administration:
Stop Use:
Stop use: do not apply to broken skin. if redness occurs, discontinue use. avoid contact with eyes.
Package Label Principal Display Panel:
Package label.principal display panel urea 20% cream for external use only. soothes, softens and moisturizes dry rough skin avkare net wt. 3 oz. (85 g) manufactured for: avkare, pulaski, tn 38478 www.avkare.com questions or comments? 1-855-361-3993 av 04/22 urea 20% cream product no. 50268-820-85 for external use only. soothes, softens and moisturizes dry rough skin avkare net wt. 3 oz. (85 g) carton tube
Further Questions:
Questions or comments? 1-855-361-3993