CEM-Urea by PruGen, Inc. CEM-UREA- urea solution

CEM-Urea by

Drug Labeling and Warnings

CEM-Urea by is a Prescription medication manufactured, distributed, or labeled by PruGen, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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:

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. 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.

PHARMACOKINETICS

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

INDICATIONS & USAGE

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

Known hypersensitivity to any of the listed ingredients.

WARNINGS AND PRECAUTIONS

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

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.

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 CEM-UreaTM (45% Urea) 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 & ADMINISTRATION

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

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

STORAGE AND HANDLING

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

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

INGREDIENTS AND APPEARANCE

CEM-UREA 
urea solution

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	.45 mL  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
METHYLPARABEN (UNII: A2I8C7HI9T)
HYDROXYETHYL CELLULOSE (3000 CPS AT 1%) (UNII: 7Q6P4JN1QT)
WATER (UNII: 059QF0KO0R)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTUS OIL (UNII: 2R04ONI662)
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
MENTHOL (UNII: L7T10EIP3A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42546-100-20	1 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)