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Urea 50 Gel

Pronunciation

Generic Name: urea
Dosage Form: gel, applicator

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.

Urea 50 Applicator

DESCRIPTION:

Urea 50 Applicator contains a keratolytic solution, which is a gentle, yet potent, tissue softener for nails and dry rough skin. Urea 50 Applicator contains 50% urea along with acrylates copolymer, carbomer, cetyl alcohol, disodium EDTA, dl-alphatocopheryl acetate, glycerin, lactic acid, linoleic acid, mineral oil, PEG-6, polysorbate 60, purified water, sodium hydroxide solution, stearic acid, titanium dioxide, zinc undecylenate.

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

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CLINICAL PHARMACOLOGY:

Urea gently dissolves the intercellular matrix, which results in loosening the horny layer of skin while shedding scaly skin at regular intervals, which then softens the 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 AND USES:

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 hyper-keratotic conditions such as dry, rough skin, dermatitis, psoriasis, ichthyosis, keratoderma, eczema, keratosis pilaris, keratosis palmaris, xerosis, 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.

PRECAUTIONS:

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, Urea 50 Applicator should be given to pregnant women 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 Urea 50 Applicator is administered to nursing women.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

ADVERSE REACTIONS:

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

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

DOSAGE AND ADMINISTRATION:

Apply Urea 50 Applicator to diseased or damaged nail and/or skin tissue twice per day, or as directed by a physician.

HOW SUPPLIED:

Urea 50 Applicator, NDC #49769-404-12, is supplied in a carton containing three 4 mL pre-filled applicators. Net wt. 12 mL.

STORAGE:

Store at controlled room temperature 15°C–30°C (59°F–86° F).

Protect from freezing.

Manufactured for:
Kylemore Pharmaceuticals
Suwanee, GA 30024
Rev. 12/09 404-10

PACKAGING:

Urea 50 Applicator labeling:

Urea 50 Applicator carton:

UREA 50 
urea gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49769-404
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 500 mg  in 1 mL
Packaging
# Item Code Package Description
1 NDC:49769-404-12 12 mL in 1 APPLICATOR
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/06/2010
Labeler - Kylemore Pharmaceuticals, LLC (831892471)
Revised: 01/2010
 
Kylemore Pharmaceuticals, LLC



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