Urea 50% Emulsion

UREA 50% EMULSION — urea emulsion
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.

In a zinc undecylenate and lactic acid vehicle

For external use only.

Not for ophthalmic use.

DESCRIPTION:

Each gram of Urea 50% Emulsion contains 50% urea in a formulation consisting of: caprylic/capric triglyceride, cetyl alcohol, disodium EDTA, glycerin, hydroxyethylcellulose, lactic acid, linoleic acid, PEG-6, polysorbate 60, propylene glycol, sorbitan stearate, titanium dioxide, triethanolamine, purified water, vitamin E, xanthan gum and zinc undecylenate.

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

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. Ureais 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 Emulsion 50% 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 50% Emulsion 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 50% Emulsion to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.

HOW SUPPLIED:

Urea 50% Emulsion is supplied as a: 10 oz tube, NDC 0168-0646-10

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:
Pegasus Laboratories, Inc.
Pensacola, FL 32514

IL383A

R8/08

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How to properly use UREA 50% EMULSION In a zinc undecylenate and lactic acid vehicle

Fougera® Rx only

May help in treatment of dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris, keratoderma, dermatitis, pruritus, eczema, corns and calluses.

For skin:

  1. Apply Urea 50% Emulsion to affected skin twice per day, or as directed by a physician.
  2. Rub in until completely absorbed (for best results apply to moistened skin).
  3. Avoid contact with eyes, lips, and mucous membranes. Wash hands after application. See full prescribing information on reverse side.

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PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 10 oz TUBE LABEL

NDC 0168-0646-10

Fougera®

UREA 50%

EMULSION

In a zinc undecylenate

and lactic acid vehicle

For Topical Use Only

Rx

Net Wt. 10 oz

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

Tube Label Front
(click image for full-size original)
Tube Label Back
(click image for full-size original)

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 10 oz CARTON

NDC 0168-0646-10

Fougera®

UREA 50%

EMULSION

In a zinc undecylenate

and lactic acid vehicle

For Topical Use Only

Not for Ophthalmic Use

Rx only

Net Wt. 10 oz

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

Carton Label
(click image for full-size original)
UREA 50% EMULSION
urea emulsion
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0646
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
polyethylene glycol 300
polysorbate 60
propylene glycol
sorbitan monostearate
titanium dioxide
trolamine
water
alpha-tocopherol
xanthan gum
zinc undecylenate
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0646-10 1 TUBE (1 TUBE) in 1 CARTON contains a TUBE
1 283.59 g in 1 TUBE This package is contained within the CARTON (0168-0646-10)
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: 09/2009 E. FOUGERA & CO., A division of Nycomed US Inc.

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