Uramaxin

Medimetriks Pharmaceuticals, Inc.

Uramaxin (45% UREA) CREAM

FULL PRESCRIBING INFORMATION: CONTENTS*

• URAMAXIN DESCRIPTION
• CLINICAL PHARMACOLOGY
  • PHARMACOKINETICS
• INDICATIONS AND USES
• URAMAXIN CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • PREGNANCY
  • NURSING MOTHERS
• URAMAXIN ADVERSE REACTIONS
• URAMAXIN DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 255 g Carton

FULL PRESCRIBING INFORMATION

Rx Only

In a vehicle containing Menthol, Camphor and Eucalyptus Oil

For external use only. Not for ophthalmic use.

URAMAXIN DESCRIPTION

Uramaxin^® (45% Urea) Cream is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Uramaxin^® (45% Urea) Cream contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, propylene glycol and purified water.

Urea is a diamide of carbonic acid with the following 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, keratoderma, corns and calluses, as well as damaged, devitalized and ingrown nails.

URAMAXIN 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, Uramaxin^® (45% Urea) Cream should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Uramaxin^® (45% Urea) Cream is administered to a nursing woman.

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

URAMAXIN ADVERSE REACTIONS

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

URAMAXIN DOSAGE AND ADMINISTRATION

Apply Uramaxin^® (45% Urea) Cream to affected skin twice per day, or as directed by a physician. Apply to diseased or damaged nails twice per day, or as directed by a physician.

HOW SUPPLIED

Uramaxin^® (45% Urea) Cream
9 oz. tube, NDC 43538-210-09

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

Protect from freezing.

Manufactured for:

MEDIMETRIKS
PHARMACEUTICALS, INC.

363 Route 46 West
Fairfield, NJ 07004-2402 USA

www.medimetriks.com

Manufactured by:
Groupe PARIMA, Inc.
Montreal, QC H4S 1X6 CANADA

IP002-R1
Iss. 7/09

PRINCIPAL DISPLAY PANEL - 255 g Carton

NDC 43538-210-09

Rx Only
Uramaxin ^®
(45% UREA) CREAM

In a vehicle containing
Menthol, Camphor
and Eucalyptus Oil

FOR TOPICAL USE ONLY

Net Wt. 9 oz (255 g)

MEDIMETRIKS
PHARMACEUTICALS, INC.