CEM-Urea

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.

Stop using urea topical and call your doctor at once if you have:

• severe redness or irritation of treated skin.

Common side effects may include:

• mild itching; or
• mild burning or stinging.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

There are many brands and forms of urea topical available and not all brands are listed on this leaflet.

Urea topical (for the skin) is used to soften rough or dry skin caused by skin conditions such as eczema, psoriasis, keratosis, and others. Urea topical is also used to soften damaged fingernails or toenails so they can be removed without surgery.

Urea topical may also be used for purposes not listed in this medication guide.

Use the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not use extra medicine to make up the missed dose.

• If you have an allergy to urea or any other part of CEM-Urea (urea cream, lotion, gel, ointment, and solution).
• If you are allergic to any drugs like this one, any other drugs, foods, or other substances. Tell your doctor about the allergy and what signs you had, like rash; hives; itching; shortness of breath; wheezing; cough; swelling of face, lips, tongue, or throat; or any other signs.

This medicine may interact with other drugs or health problems.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take this medicine with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

• Tell all of your health care providers that you take CEM-Urea. This includes your doctors, nurses, pharmacists, and dentists.
• Do not put on irritated skin.
• Use care when putting on a large part of the skin or where there are open wounds. Talk with the doctor.
• If you use this medicine too often, your skin problem may become worse.
• Do not use longer than you have been told by the doctor.
• Talk with your doctor before you use other drugs or products on your skin.
• Tell your doctor if you are pregnant or plan on getting pregnant. You will need to talk about the benefits and risks of using CEM-Urea while you are pregnant.
• Tell your doctor if you are breast-feeding. You will need to talk about any risks to your baby.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Very bad skin irritation.

CEM-UreaTM (45% Urea) is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of CEM-UreaTM (45% Urea) contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, methyl paraben, propylene glycol and purified water.
Urea is a diamide of carbonic acid with the following chemical structure:

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

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.

Known hypersensitivity to any of the listed ingredients.

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 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, CEM-UreaTM (45% Urea) should be given to a pregnant woman only if clearly needed.

 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.

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

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.

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

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

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

CEM-Urea  urea solution

Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42546-100 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA .45 mL  in 1 mL

Inactive Ingredients Ingredient Name Strength PROPYLENE GLYCOL   METHYLPARABEN   HYDROXYETHYL CELLULOSE (3000 CPS AT 1%)   WATER   EDETATE DISODIUM   EUCALYPTUS OIL   CAMPHOR (SYNTHETIC)   MENTHOL

Packaging # Item Code Package Description 1 NDC:42546-100-20 1 APPLICATOR (APPLICATOR) in 1 BOX 1 20 mL in 1 APPLICATOR

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/01/2011

Labeler - PruGen, Inc. (929922750)

Revised: 08/2011   PruGen, Inc.

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Skin irritation.
• Burning.
• Stinging.
• Itching.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of CEM-Urea may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.