CEM-UREA TM PRE-FILLED APPLICTOR REV.1.0

DESCRIPTION SECTION

CLINICAL PHARMACOLOGY SECTION

PHARMACOKINETICS SECTION

INDICATIONS & USAGE SECTION

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 SECTION

WARNINGS AND PRECAUTIONS SECTION

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

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 SECTION

Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studiesin pregnant women. Because animal reproductive studies are not always predictive of human response, CEM-UreaTM (45% Urea) should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS SECTION

 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 CEM-UreaTM (45% Urea) is administered to a nursing woman.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

ADVERSE REACTIONS SECTION

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

DOSAGE & ADMINISTRATION SECTION

DIRECTIONS FOR NAILS: Apply CEM-UreaTM (45% Urea) to diseased or damaged nail tissue twice per day, or as directed by a physician.DIRECTIONS FOR SKIN: Apply CEM-UreaTM (45% Urea) to affected area(s) twice per day, or as directed by a physician.

HOW SUPPLIED SECTION

CEM-UreaTM (45% Urea) 20 mL tube, NDC 42546-100-20

STORAGE AND HANDLING SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42546-100-20

CEM-Urea Pre-Filled Applicator 45% urea

In a vehicle containing Menthol, Camphor, and Eucalyptus Oil

Rx only

0.68 FL OZ (20 mL)

PruGen, Inc. Pharmaceuticals