Urea 45% Cream

UREA  - urea cream 
River's Edge Pharmaceuticals, LLC

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Urea 45% Cream

1 INDICATIONS AND USAGE

Urea 45% Cream is indicated for the debridement and promotion of the normal healing of hyperkeratotic surface lesions, particularly where healing is delayed 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.

2 DOSAGE AND ADMINISTRATION

DIRECTIONS: Apply RIVER’S EDGE Urea 45% Cream to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.

3 DOSAGE FORM AND STRENGTH

45% Urea/g cream topical preparation

4 CONTRAINDICATIONS

Known hypersensitivity or intolerance to any component of this product.

5 WARNINGS AND PRECAUTIONS

KEEP OUT OF REACH OF CHILDREN.
5.1 General: For external use only. Avoid contact with eyes, lips or mucous membranes. If swallowed seek medical attention or contact a Poison Control Center immediately.
5.2 Information for the Patient: Use this medication only as directed by a physician. It should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.

6 ADVERSE REACTIONS

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

To report SUSPECTED ADVERSE REACTIONS, contact FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

8 USE IN SPECIFIC POPULATIONS

8.1 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 reproduction studies are not always predictive of human response, Urea 45% Cream should be given to a pregnant woman only if clearly needed.
8.3 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 45% Cream is administered to a nursing woman.

11 DESCRIPTION

Urea 45% Cream is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin.

Each gram of Urea 45% Cream contains 45% Urea. Other ingredients: Camphor, Edetate Disodium, Ethyl Alcohol SD 40 B, Eucalyptus Oil, Hydroxyethyl Cellulose, Menthol, Purified Water, Titanium Dioxide, Sodium Hydroxide 50% Solution.

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

structure

12 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.
12.1 Pharmacokinetics: The mechanism of action of topically applied Urea is not yet known.

16 HOW SUPPLIED/STORAGE AND HANDLING

16.1 Urea 45% Cream is supplied as follows:
SIZE: 9 oz. tube NDC #: 68032-429-09
16.2 Storage Conditions:
Store at controlled room temperature 15-30° C (59°-86°F).
Protect from freezing.

17 PATIENT COUNSELING INFORMATION

17.1 GENERAL INFORMATION
Patients should be advised of the following:
• For external use only.
• Avoid contact with eyes, lips or mucous membranes.
• Temporary stinging, burning, itching, or irritation may occur and normally disappear on discontinuation of the medication.
*Sections or subsections omitted from the full prescribing information are not listed.

Manufactured for:
River’s Edge Pharmaceuticals, LLC.
Suwanee, GA 30024
Rev. 08/09 429-10

PACKAGING

Urea 45% Cream Labeling:

label

Urea 45% Cream Carton:

carton



UREA 
urea   cream
Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)68032-429
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
UREA (UREA) UREA450 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
CAMPHOR 
EDETATE DISODIUM 
ALCOHOL 
EUCALYPTUS OIL 
HYDROXYETHYL CELLULOSE (140 CPS AT 5%) 
MENTHOL 
WATER 
TITANIUM DIOXIDE 
SODIUM HYDROXIDE 
Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#NDCPackage DescriptionMultilevel Packaging
168032-429-09255 g In 1 TUBENone

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/20/2010

Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 01/2010River's Edge Pharmaceuticals, LLC