NDC 61344-452 Uremol

Urea

NDC Product Code 61344-452

NDC Product Information

Uremol with NDC 61344-452 is a a human over the counter drug product labeled by Odan Laboratories Ltd. The generic name of Uremol is urea. The product's dosage form is lotion and is administered via topical form.

Labeler Name: Odan Laboratories Ltd

Dosage Form: Lotion - An emulsion, liquid1 dosage form. This dosage form is generally for external application to the skin.2

Product Type: Human Otc 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.

Uremol 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 100 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.

  • POTASSIUM PHOSPHATE, MONOBASIC (UNII: 4J9FJ0HL51)
  • PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
  • SODIUM PHOSPHATE DIBASIC DIHYDRATE (UNII: 94255I6E2T)
  • GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
  • PROPYLPARABEN (UNII: Z8IX2SC1OH)
  • CAPRYLIC/CAPRIC ACID (UNII: DI775RT244)
  • TRICAPRILIN (UNII: 6P92858988)
  • CARBOMER 940 (UNII: 4Q93RCW27E)
  • CETEARETH-12 (UNII: 7V4MR24V5P)
  • POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)
  • DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)
  • GLYCERIN (UNII: PDC6A3C0OX)
  • WATER (UNII: 059QF0KO0R)
  • XANTHAN GUM (UNII: TTV12P4NEE)
  • METHYLPARABEN (UNII: A2I8C7HI9T)
  • OCTYLDODECANOL (UNII: 461N1O614Y)

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: Odan Laboratories Ltd
Labeler Code: 61344
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: 05-31-2019 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.

Uremol 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

Active Ingredient

Urea 10%

Inactive Ingredients

Caprylic, Caprylic triglyceride, carbomer 940, ceteareth-12, ceteareth-20, citrid acid, diazolidinyl urea, purified water, glycerin, xanthan gum, methylparaben, glyceryl monostearate, octyldodecanol, sodium phosphate dibasic, potassium phosphate monobasic, propylene glycol, propylparaben,

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.

Otc - Purpose

Uremol 10% lotion temporarily protects and helps relieve minor skin irritation and itching..

Dosage & 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.

Otc - Keep Out Of Reach Of Children

For external use only. Keep out of reach and sight of children. Store between 15-30
0C.

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.

* Please review the disclaimer below.

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