Uramaxin GT

Generic Name: urea

Dosage Form: gel, pre-filled-applicator
Uramaxin(45% Urea)GT PRE-FILLED APPLICATOR

PATIENT INSTRUCTIONS

1. Apply Uramaxin GT to affected nails or skin twice per day, or as directed by a physician.

2. After application, wipe the tip of the tube to remove excess product. Securely place cap back on the tube.

DESCRIPTION:Uramaxin (45% Urea) GT is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Uramaxin (45% Urea) GT 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.

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) GT 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) GT 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: DIRECTIONS FOR NAILS: Apply Uramaxin (45% Urea) GT to diseased or damaged nail tissue twice per day, or as directed by a physician.

DIRECTIONS FOR SKIN: Apply Uramaxin (45% Urea) GT to affected area(s) twice per day, or as directed by a physician.

HOW SUPPLIED:

Uramaxin (45% Urea) GT 20 mL tube, NDC 43538-250-20

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

URAMAXIN  GT urea  gel

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43538-250 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 0.45 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength CAMPHOR (SYNTHETIC)   EDETATE DISODIUM   EUCALYPTUS OIL   HYDROXYETHYL CELLULOSE (4000 CPS AT 1%)   LEVOMENTHOL   PROPYLENE GLYCOL   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 43538-250-20 1 TUBE In 1 CARTON contains a TUBE, WITH APPLICATOR 1 20 mL In 1 TUBE, WITH APPLICATOR This package is contained within the CARTON (43538-250-20) 2 43538-250-99 5 mL In 1 TUBE, WITH APPLICATOR None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/08/2010

Labeler - Medimetriks Pharmaceuticals, Inc. (019903816)

Registrant - Groupe PARIMA, Inc. (252437850)

Establishment
Name	Address	ID/FEI	Operations
Groupe PARIMA, Inc.		252437850	manufacture

Revised: 07/2010Medimetriks Pharmaceuticals, Inc.

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