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Name:Urea
Manufacturer:River's Edge Pharmraceuticals, Llc
Category:Prescription Marketed Drugs


UREA  - urea gel 
River's Edge Pharmraceuticals, LLC

Disclaimer: 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.

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Indications & Usage:

Urea 45% Nail Gel 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.

Dosage & Administration:

Apply RIVER ’S ED GE 45% UREA NAIL GEL to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.

Dosage Forms & Strengths:

45% Urea/g gel topical preparation

Contraindications:

Known hypersensitivity to any of the listed ingredients.

Warnings & Precautions:

KEEP OUT OF REACH OF CHILDREN.
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.

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.

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.

Use In Specified Populations:

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% Nail Gel 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 45% Nail Gel is administered to a nursing woman.

Description:

Urea 45% Nail Gel is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea 45% Nail Gel contains 45% Urea. Other ingredients: Camphor, Disodium EDTA, Eucalyptus Oil, Hydroxyethylcellulose, Menthol, Propylene Glycol, and Purified Water.

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.

How Supplied:

Urea 45% Nail Gel is supplied as follows: SIZE: 28 mL bottle NDC #: 68032-421-28

Storage & Handling:

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

Patient Counseling Information:

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.

Bottle Label:

label


UREA 
urea gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-421
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 450 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (SYNTHETIC)  
EDETATE DISODIUM  
EUCALYPTUS OIL  
MENTHOL  
PROPYLENE GLYCOL  
WATER  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-421-28 28 mL in 1 BOTTLE, WITH APPLICATOR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 08/07/2009 10/31/2012

Labeler - River's Edge Pharmraceuticals, LLC (133879135)

Revised: 12/2010 River's Edge Pharmraceuticals, LLC



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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