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Name:Urea
Manufacturer:Physicians Total Care, Inc.
Category:Prescription Marketed Drugs


UREA CREAM 40%

UREA  - urea cream 
Physicians Total Care, 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.

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UREA CREAM 40%

Rx only

For external use only. Not for ophthalmic use.

DESCRIPTION

Urea Cream 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea Cream 40% contains 40% urea and the following inactive ingredients: carbomer, cetyl alcohol, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, triethanolamine 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. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

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, as well as damaged, ingrown and devitalized nails.

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 reproductive studies are not always predictive of human response, Urea Cream 40% 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 Cream 40% 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 Cream 40% to affected skin twice per day, or as directed by a physician. Rub in until cream is completely absorbed.

Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

HOW SUPPLIED

Urea Cream 40% is supplied as a:

85 g (3 oz) tube, NDC 54868-5880-1

198.6 g (7 oz) tube, NDC 54868-5880-0


Store at room temperature 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:
Groupe PARIMA, Inc.
Montreal, QC H4S 1X6 CANADA

IL273A

R9/08



Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK      74146

INSTRUCTIONS FOR USE

fougera®

UREA CREAM 40%

Rx only

Steps to help gently thin and soften areas of thick, rough or dry skin, as well as damaged, diseased or devitalized and ingrown nails. See back page for full prescribing information, including Indications and Uses.

For skin:

  1. Apply Urea Cream 40% to affected skin twice per day, or as directed by a physician.
  2. Rub in until completely absorbed.

For nail(s):

  1. Apply Urea Cream 40% to affected nail(s) twice per day, or as directed by a physician.
  2. Let dry uncovered or apply and cover with adhesive bandage or gauze secured with adhesive tape.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 7 OZ

Rx only

image of package label

Urea Cream 40%

For Topical Use Only

NET WT. 7 OZ (198.6 g)



UREA 
urea cream
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:54868-5880(NDC:0168-0485)
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 0.4 g  in 1 g
Inactive Ingredients
Ingredient Name Strength
WATER  
CARBOMER HOMOPOLYMER TYPE C  
PROPYLENE GLYCOL  
XANTHAN GUM  
PETROLATUM  
MINERAL OIL  
CETYL ALCOHOL  
TROLAMINE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:54868-5880-0 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
1 199 g in 1 TUBE This package is contained within the CARTON (54868-5880-0)
2 NDC:54868-5880-1 1 TUBE ( TUBE) in 1 CARTON contains a TUBE
2 85 g in 1 TUBE This package is contained within the CARTON (54868-5880-1)

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 03/28/2008

Labeler - Physicians Total Care, Inc. (194123980)
Establishment
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel

Revised: 09/2009 Physicians Total Care, Inc.



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


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