Uramaxin

Medimetriks Pharmaceuticals, Inc.
Groupe PARIMA, Inc.

Uramaxin(45% Urea)TS

FULL PRESCRIBING INFORMATION

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.

Uses

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

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