Uramaxin TS Cream

Generic Name: urea

Dosage Form: cream
Uramaxin(45% Urea)TS

PATIENT INSTRUCTIONS

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

2. For best results, apply Uramaxin TS to moistened skin, such as after a shower or bath.

3. After Uramaxin TS has dried completely, if any excess appears, simply wipe skin with a damp cloth.

DESCRIPTION:  Uramaxin (45% Urea) TS is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin.  Each gram of Uramaxin (45% Urea) TS contains 45% urea in a formulation consisting of acrylates/acrylamide copolymer, camphor, caprylic/capric triglycerides, carbomer interpolymer type A, cetyl alcohol, cholesterol, coco-glycerides, dl-alpha tocopheryl acetate, edetate disodium, eucalyptus oil, glyceryl monostearate, linoleic acid, linolenic acid, menthol (-L-), mineral oil, octyldodecanol, polysorbate 85, propylene glycol, purified water, seed extract, trolamine, xanthan gum.

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.

PHARMACOKINETICS:  The mechanism of action of topically applied Urea is not yet known.

INDICATION 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.

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) TS should be given to pregnant women 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) TS 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 Uramaxin (45% Urea) TS to affected skin twice per day, or as directed by a physician.

HOW SUPPLIED:

Uramaxin (45% Urea) TS

Net wt. 14 oz. (397g) tube, NDC 43538-240-14

Also available:

Uramaxin (45% Urea) Cream

Net wt. 9 oz. (255 g) tube, NDC 43538-210-09


Uramaxin (45% Urea) Nail Gel

28 mL bottle, NDC 43538-200-28


Uramaxin (45% Urea) Lotion

16 fl.oz. (473 mL) bottle, NDC 43538-230-16


Store at controlled room temperature 15o-30oC (59o-86oF).


Protect from freezing.


Manufactured for:


MEDIMETRIKS

PHARMACEUTICALS, INC.


363 Route 46 West. Fairfield, NJ 07004-2402 USA


wwww. medimetriks.com


Manufactured by:

Groupe Parima, Inc. Montreal, QC H4S 1X6 CANADA

URAMAXIN  TS urea   cream

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 43538-240 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)   MEDIUM-CHAIN TRIGLYCERIDES   CARBOMER INTERPOLYMER TYPE A (55000 CP)   CETYL ALCOHOL   CHOLESTEROL   COCO-GLYCERIDES   .ALPHA.-TOCOPHEROL ACETATE, DL-   EDETATE DISODIUM   EUCALYPTUS OIL   GLYCERYL MONOSTEARATE   LINOLEIC ACID   LINOLENIC ACID   LEVOMENTHOL   MINERAL OIL   OCTYLDODECANOL   PROPYLENE GLYCOL   WATER   HELIANTHUS ANNUUS   TROLAMINE   XANTHAN GUM

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 43538-240-14 1 TUBE In 1 CARTON contains a TUBE 1 397 g In 1 TUBE This package is contained within the CARTON (43538-240-14) 2 43538-240-99 5 g In 1 TUBE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/20/2010

Labeler - Medimetriks Pharmaceuticals, inc. (019903816)

Registrant - Groupe Parima, inc. (252437850)

Establishment
Name	Address	ID/FEI	Operations
Groupe Parima, inc.		252437850	manufacture

Revised: 04/2010Medimetriks Pharmaceuticals, inc.

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