Rx Only

For external use only. Not for ophthalmic use.

DESCRIPTION

45% Urea Lotion is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of 45% Urea Lotion contains 45% Urea in a formulation consisting of Camphor, Disodium EDTA, Alcohol SDA 40, Eucalyptus Oil, Hydroxyethylcellulose, Menthol, Water and Titanium Dioxide.

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.

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.

CONTRAINDICATIONS

Known hypersensitivity to any of the listed ingredients.

WARNINGS

For external use only. Avoid contact with eyes, lips or mucus 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.

ADVERSE REACTIONS

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

DOSAGE AND ADMINISTRATION

Apply 45% Urea Lotion to affected skin twice per day, or as directed by a physician.

HOW SUPPLIED

45% Urea Lotion is supplied as a 16oz bottle, NDC 61269-182-16

PRINCIPAL DISPLAY PANEL - 454 g Bottle Label

NDC 61269-182-16

Rx Only

45% Urea
Lotion
45% Urea

In a vehicle containing
Camphor, Eucalyptus Oil
and Menthol

FOR TOPICAL USE ONLY

Net Wt. 16 oz.

H2 pharma