Uramaxin Pads

URAMAXIN PADS- urea cloth
Medimetriks Pharmaceuticals, 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.

For external use only. Not for ophthalmic use.

DESCRIPTION: Uramaxin® (45% Urea) Pads contain a 45% solution of urea on a textured cloth. Each gram of medicated solution 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:

Structure Urea
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CLINICAL PHARMACOLOGY: Urea gently dissolves the intercellular matrix, which results in loosening of 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 reproductive studies are not always predictive of human response, Uramaxin® (45% Urea) Pads 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) Pads 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: Gently apply Uramaxin® (45% Urea) Pad to affected area(s) twice daily, or as directed by a physician. After application, discard pad. Do not flush.

HOW SUPPLIED: Uramaxin® (45% Urea) Pads NDC 43538-260-45, are supplied in a carton containing 45 foil pouches, each with a single-use medicated cloth (15 g each).

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


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
Sachet
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Carton
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URAMAXIN PADS urea cloth
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:43538-260
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 450 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (SYNTHETIC)
EDETATE DISODIUM
EUCALYPTUS OIL
HYDROXYETHYL CELLULOSE (4000 CPS AT 1%)
LEVOMENTHOL
PROPYLENE GLYCOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43538-260-45 45 POUCH (POUCH) in 1 CARTON contains a POUCH
1 15 g in 1 POUCH This package is contained within the CARTON (43538-260-45)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/07/2010
Labeler — Medimetriks Pharmaceuticals, Inc. (019903816)
Registrant — Groupe PARIMA, Inc. (252437850)
Establishment
Name Address ID/FEI Operations
Groupe PARIMA, Inc. 252437850 manufacture

Revised: 10/2010 Medimetriks Pharmaceuticals, Inc.

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