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Name:Urea40
Manufacturer:Kylemore Pharmaceuticals, Llc
Category:Prescription Marketed Drugs


Urea 40 Gel/Lotion

UREA 40 - urea gel 
Kylemore Pharmaceuticals, 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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Urea 40 Gel/Lotion

DESCRIPTION:

Urea 40 Gel/Lotion is a keratolytic, emollient which is a gentle, yet potent, tissue softener for nails and/or skin.

Each gram of Urea 40 Lotion contains 40% Urea, carbomer, cetyl alcohol, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, triethanolamine and xanthan gum.

Each gram of Urea 40 Gel contains 40% Urea, caprylic/capric glycerides, disodium EDTA, glycerin, PEG-6 hydroxyethylcellulose, water, xanthan gum. 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 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 prurient 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, ingrown and devitalized 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 C. Animal reproduction studies have not been conducted with Urea 40 Gel/Lotion. It is also now known whether Urea 40 Gel/Lotion can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Urea 40 Gel/Lotion should be given to a pregnant woman 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 40 Gel/Lotion 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 Urea 40 Gel/Lotion to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day, or as directed by a physician.

HOW SUPPLIED:

Urea 40 Gel or Lotion supplied as a:
Gel: 15 mL (1/2 oz.) bottle, NDC 49769-101-15
Lotion: 8 oz. bottle, NDC 49769-101-08

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

Manufactured for:
Kylemore Pharmaceuticals
Port St. Joe, FL 32456
101-10 Rev. 12/09

PACKAGING:

Urea 40 Gel Carton:

carton

Urea 40 Gel Label:

label


UREA  40
urea gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49769-101
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 40 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM  
GLYCERIN  
HYDROXYETHYL CELLULOSE (140 CPS AT 5%)  
POLYETHYLENE GLYCOL 300  
WATER  
XANTHAN GUM  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49769-101-08 226.8 g in 1 BOTTLE None
2 NDC:49769-101-15 15 g in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/01/2009 12/31/2012

Labeler - Kylemore Pharmaceuticals, LLC (831892471)

Revised: 03/2011 Kylemore Pharmaceuticals, LLC



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


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