Uremol
Urea
Odan Laboratories Ltd
Human Otc Drug
NDC 61344-452Uremol also known as Urea is a human otc drug labeled by 'Odan Laboratories Ltd'. National Drug Code (NDC) number for Uremol is 61344-452. This drug is available in dosage form of Lotion. The names of the active, medicinal ingredients in Uremol drug includes Urea - 100 mg/mL . The currest status of Uremol drug is Active.
Drug Information:
| Drug NDC: | 61344-452 |
| 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: | Uremol |
| 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: | Odan Laboratories Ltd |
| Name of Company corresponding to the labeler code segment of the ProductNDC. |
| Dosage Form: | Lotion |
| 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 - 100 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: | 31 May, 2019 |
| 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: | Odan Laboratories Ltd
|
| Name of manufacturer or company that makes this drug product, corresponding to the labeler code segment of the NDC. |
| RxCUI: | 198884
|
| 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 |
|---|
| 61344-452-30 | 250 mL in 1 BOTTLE (61344-452-30) | 31 May, 2019 | 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:
Uremol 10% lotion temporarily protects and helps relieve minor skin irritation and itching..
Product Elements:
Uremol urea potassium phosphate, monobasic propylene glycol sodium phosphate dibasic dihydrate glyceryl monostearate propylparaben caprylic/capric acid tricaprilin carbomer 940 ceteareth-12 polyoxyl 20 cetostearyl ether diazolidinyl urea glycerin water xanthan gum methylparaben octyldodecanol urea urea
Indications and Usage:
Indication and usage uremol temporarily protects and helps relieve minor skin irritation and itching. apply to skin up to 3 times/day. do not use under 2 years old, unless directed by a physician. used on children should be supervised by an adult. stop use if condition worsens.
Warnings:
Warning don't use if allergic to urea or any other ingredients in uremol. avoid contact with eyes and mucous membrane; in case of contact, wash with water. after application you may notice rash, itchiness, irritation, pain, reddening, burning or discoloration of the skin, which could be sign of an allergic reaction. stinging may occur if applied to damaged skin. if too much is applied, irritation may occur. if irritation worsens or persists, discontinue temporarily. consult a health care professional if symtoms worsen or last for more than 7 days or if using other topical product on your skin.
Dosage and Administration:
Uremol 10 % temporarily protects and helps relieve minor skin irritation and itching. apply to skin up to 3 times/day. do not use on children under 2 years old.
Package Label Principal Display Panel:
Uremol lotion