You are here: Home > Prescription(RX) Drugs > U > Urea (E. Fougera & Co., A Division Of Nycomed Us Inc.)

Name:Urea
Manufacturer:E. Fougera & Co., A Division Of Nycomed Us Inc.
Category:Prescription Marketed Drugs


UREA TOPICAL SUSPENSION 50%

UREA - urea solution 
E. FOUGERA & CO., A division of Nycomed US Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

UREA TOPICAL SUSPENSION 50%

In a lactic acid & salicylic acid vehicle

Rx only

For external use only. Not for ophthalmic use.

DESCRIPTION

Each gram of Urea Topical Suspension contains 50% urea in a formulation consisting of caprylic/capric triglyceride, carbomer, cetyl alcohol, edetate disodium, glycerin, hydroxyethylcellulose, lactic acid, linoleic acid, PEQ-6, polysorbate 60, propylene glycol, purified water, salicylic acid, sorbitan stearate, titanium dioxide, triethanolamine, vitamin E and xanthan gum.

Urea is a diamide of carbonic acid with the following chemical structure:

Chemical Structure

CLINICAL PHARMACOLOGY

Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas.

PHARMACOKINETICS: The mechanism of action of topically applied Urea is not yet known.

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 pilaris, keratosis palmaris, keratoderma, corns and calluses.

CONTRAINDICATIONS

Known hypersensitivity to any of the listed ingredients.

WARNINGS

For external use only. Avoid contact with eyes, lips or mucous membranes.

PRECAUTIONS

This medication 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.

PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Urea Topical Suspension should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea Topical Suspension is administered to a nursing woman.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

ADVERSE REACTIONS

Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.

DOSAGE AND ADMINISTRATION

Apply Urea Topical Suspension to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.

HOW SUPPLIED

Urea Topical Suspension 50% is supplied as:

284 g (10 oz) tube, NDC 0168-0493-84

Store at room temperature 15°-30° C (59°-86° F).

Protect from freezing.

Manufactured for: E. F0UGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

Manufactured by: Pegasus Laboratories, Inc.
Pensacola, FL 32514

IL339A

R4/09

How to properly use
fouqera®
UREA TOPICAL SUSPENSION 50%

In a lactic acid & salicylic acid vehicle

Rx only

Steps to treat dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris, keratoderma, dermatitis, eczema, corns and calluses.

For skin:

  1. Apply Urea Topical Suspension to affected skin twice per day, or as directed by a physician.
  2. Rub in until completely absorbed.

See other side for full prescribing information.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 10 OZ CONTAINER

NDC 0168-0493-84

Fougera®

UREA TOPICAL
SUSPENSION 50%

In a lactic acid &
salicylic acid vehicle

For Topical Use Only

Rx only

Net Wt. 10 oz (284 g)

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

Container

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 10 OZ CARTON

NDC 0168-0493-84

Fougera®

UREA TOPICAL
SUSPENSION 50%

In a lactic acid &
salicylic acid vehicle

For Topical Use Only

Rx only

Net Wt. 10 oz (284 g)

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

Carton

UREA 
urea solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0493
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
urea (urea) urea 500 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
cetyl alcohol  
edetate disodium  
glycerin  
lactic acid  
linoleic acid  
polyethylene glycol 300  
polysorbate 60  
propylene glycol  
water  
salicylic acid  
sorbitan monostearate  
titanium dioxide  
trolamine  
alpha-tocopherol  
xanthan gum  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0493-84 284 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 09/15/2009

Labeler - E. FOUGERA & CO., A division of Nycomed US Inc. (043838424)
Registrant - Nycomed US Inc. (043838424)

Revised: 09/2009 E. FOUGERA & CO., A division of Nycomed US Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


Copyright © 2017 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

Prescription Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback