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Urea Ointment

Pronunciation

Dosage Form: ointment

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.

Kylemore 50% Urea Ointment

DESCRIPTION:

Kylemore 50% Urea Ointment is a keratolytic emollient, which is a gentle, yet potent, tissue softener for skin. Each gram of Kylemore 50% Urea Ointment contains 50% Urea, Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Edetate Disodium, Glycerin, Hydroxyethylcellulose, Lactic Acid, Linoleic Acid, PEG-6, Polysorbate 60, Propylene Glycol, Purified Water, Sorbitan Stearate, Tocopherol (Vitamin E), Triethanolamine, Xanthan Gum, and Zinc Pyrithione.

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 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 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 hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses.

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, Kylemore 50% Urea Ointment 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 Kylemore 50% Urea Ointment 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 AND ADMINISTRATION:

Apply Kylemore 50% Urea Ointment to affected skin twice per day, or as directed by a physician.

HOW SUPPLIED:

Kylemore 50% Urea Ointment is supplied as a 45g (1.5 oz) tube, NDC 68032-130-45.
Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.

Manufactured for:
Kylemore Pharmaceuticals
Suwanee, GA 30024
Rev. 12/09 130-10

PACKAGING:

Kylemore 50% Urea Ointment carton:

UREA 
Urea Ointment
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:49769-130
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 500 mg  in 1 g
Packaging
# Item Code Package Description
1 NDC:49769-130-45 45 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2010
Labeler - Kylemore Pharmaceuticals, LLC (831892471)
Revised: 01/2010
 
Kylemore Pharmaceuticals, LLC



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