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 LOTION 35%In a vehicle containing vitamin E, lactic acid and zinc

UREA - urea lotion 
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 LOTION 35%
In a vehicle containing vitamin E, lactic acid and zinc

Rx only

For external use only. Not for ophthalmic use.

DESCRIPTION

Urea Lotion 35% is a keratolytic emollient which is a gentle, yet potent, tissue softener for skin.

Each gram of Urea Lotion 35% contains 35% urea and the following inactive ingredients: caprylic/capric triglyceride, carbomer, cetyl alcohol, cholesterol, disodium EDTA, glycosphingolipids, hydrogenated polydecence, hydroxyethylcellulose, lactic acid, linoleic acid, phospholipids, polysorbate 60, PPG-5 laureth-5, purified water, sodium polyacrylate, sorbitan stearate, triethanolamine, vitamin E, xanthan gum and zinc pyrithione.

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 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 pr purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, prurutus, 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 mediation 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 reproductive studies are not always predictive of human response, Urea Lotion 35% 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 Lotion 35% is administered to a nursing woman.

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

ADVERSE REACTIONS

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

DOSAGE AND ADMINISTRATION

Apply Urea Lotion 35% to affected skin twice per day, or as directed by physician. Rub in until lotion is completely absorbed.

HOW SUPPLIED

Urea Lotion 35% is supplied as a:

7 oz (207 mL) bottle, NDC 0168-0488-07

11 oz (325 mL) bottle, NDC 0168-0488-11

Store at 15°-30° C (59°-86° F).

Protect from freezing.

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

Manufactured by: Pegasus Laboratories
Pensacola. FL 32514

IL278A

R12/08

INSTRUCTIONS FOR USE

fougera®
UREA LOTION 35%
In a vehicle containing vitamin E, lactic acid and zinc

Steps to help gently thin and soften thick, rough or dry skin seen, to various degrees, In psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris, keratoderma, dermatitis, pruritus, eczema and calluses.

For skin:

  1. Apply Urea Lotion 35% to affected skin twice per day, or as directed by a physician.
  2. Rub In until completely absorbed.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 7 oz BOTTLE LABEL

NDC 0168-0488-07

Fougera®

UREA LOTION
35%

In a vehicle containing
Vitamin E, Lactic Acid and Zinc

For Topical Use Only

Rx only

Net Wt. 7 oz (207 mL)

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

Bottle Label

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 7 oz CARTON

NDC 0168-0488-07

Fougera®

UREA LOTION
35%

In a vehicle containing
Vitamin E, Lactic Acid and Zinc

For Topical Use Only

Rx only

NET WT. 7 oz

(207 mL)

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

Carton Label

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 11 oz BOTTLE LABEL

NDC 0168-0488-11

Fougera®

UREA LOTION
35%

In a vehicle containing
Vitamin E, Lactic Acid and Zinc

For Topical Use Only

Rx only

Net Wt. 11 oz (325 mL)

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

Bottle Label

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 11 oz CARTON

NDC 0168-0488-11

Fougera®

UREA LOTION
35%

In a vehicle containing
Vitamin E, Lactic Acid and Zinc

For Topical Use Only

Rx only

NET WT. 11 oz

(325 mL)

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

Carton Label

UREA 
urea lotion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0488
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
urea (urea) urea 85 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
water  
edetate disodium  
carbomer homopolymer type c  
xanthan gum  
linoleic acid  
cholesterol  
sorbitan monostearate  
polysorbate 60  
cetyl alcohol  
alpha-tocopherol  
trolamine  
lactic acid  
pyrithione zinc  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0488-07 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
1 207 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0168-0488-07)
2 NDC:0168-0488-11 1 BOTTLE, PLASTIC (1 BOTTLE) in 1 CARTON contains a BOTTLE, PLASTIC
2 325 mL in 1 BOTTLE, PLASTIC This package is contained within the CARTON (0168-0488-11)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 09/01/2009

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

Revised: 10/2009 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