Your browser does not support JavaScript! UREA CREAM [EXACT-RX, INC.]
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UREA cream
[Exact-Rx, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE:THIS DRUG HAS NOT BEEN FOUND BY FDA TO BE SAFE AND EFFECTIVE, AND THIS LABELING HAS NOT BEEN APPROVED BY FDA. For further information about unapproved drugs, click here.
Drug Label Sections

(in a cream base)

Rx only

For external use only. Not for ophthalmic use.
Keep away from eyes, lips and mucous membranes.

DESCRIPTION: UREA CREAM 45% is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 45% Urea in a cream base of: camphor, edetate disodium, alcohol, eucalyptus oil, hydroxyethyl cellulose, menthol, purified water, titanium dioxide, sodium hydroxide.

CHEMISTRY: Urea is a diamide of carbonic acid with the following chemical structure:

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 removal of devitalized nail plate tissue.

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

INDICATIONS AND USES: Urea 45% Cream is indicated for use in the topical treatment 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: For external use only. Avoid contact with eyes, lips or mucous membranes. If swallowed seek medical attention or contact a Poison Control Centter immediately.

PRECAUTIONS: Use this medication only as directed by a physician. It should not be used to treat and condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF REACH OF CHILDREN.

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, Urea Cream 45% should be given to a pregnant woman only if clearly needed.

NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea Cream 45% is administered to a nursing woman.

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

Call your doctor for medical advice about side effects.

DOSAGE AND ADMINSTRATION: Apply Urea Cream 45% to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.

HOW SUPPLIED: Urea Cream 45% is supplied in 9 oz. (255 g) tubes, NDC 42808-0202-09.

Store at 25°C (77°F); excursions permitted to 15 to 30°C (59 to 86°F). See USP Controlled Room Temperature. Protect from freezing.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0200-99-205-01

Iss:10/11

PRINCIPAL DISPLAY PANEL

For External Use Only

NDC 42808-0202-09        Rx Only

Urea
In a vehicle containing
camphor, eucalyptus oil
and menthol

45%

CREAM

Exact-Rx.
INCORPORATED

Net Wt. 9 oz (255 g)

Carton

UREA 
urea cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:42808-202
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UREA) UREA450 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR (SYNTHETIC) 
EDETATE DISODIUM 
ALCOHOL 
EUCALYPTUS OIL 
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) 
MENTHOL 
WATER 
TITANIUM DIOXIDE 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:42808-202-091 in 1 CARTON
1255 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other08/01/2011
Labeler - Exact-Rx, Inc. (137953498)

Revised: 8/2011
 
Exact-Rx, Inc.

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