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Name:U40
Manufacturer:Kylemore Pharmaceuticals, Llc
Category:Prescription Marketed Drugs


U40 Foam

U40  - urea aerosol, foam 
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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U40 Foam

DESCRIPTION

U40 Foam is a keratolytic emollient in a water and lipid-based foam which is a gentle, but potent, tissue softener for skin and nails.

U40 Foam contains the active ingredient: Urea 40%. The inactive ingredients are: Carbomer, Colloidal Oatmeal, Dimethicone, Ethylparaben, Glycerine, Laureth 4, Methylparaben, Phenoxyethanol, Polysorbate 20, Propylparaben, Propylene Glycol, Purified Water, Stearic Acid and Triethanolamine and in propellants Butane and Propane.

CHEMICAL STRUCTURE
Urea has the following chemical structure:

structure

CLINICAL PHARMACOLOGY

Urea, topically applied, dissolves the intercellular matrix of the skin which can result in enhanced shedding of scaly, dry skin which causes a softening of the hyperkeratotic areas of the skin. Applied to the nail plate topically, urea has a similar effect on the intercellular matrix of the nail plate.

PHARMACOKINETICS

The mechanism of action of topically applied urea is not yet known.

INDICATIONS AND USAGE

For enzymatic debridement and promotion of normal healing of surface lesions, particularly where healing is halted by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea, topically applied, is useful for the treatment of hyperkeratotic conditions such as dermatitis, xerosis, ichthyosis, psoriasis, eczema, keratosis, keratoderma and dry, rough skin, as well as corns and calluses. It is also useful in the treatment of damaged, ingrown and devitalized nails.

CONTRAINDICATIONS

Known hypersensitivity to any of the listed ingredients.

WARNINGS

U40 Foam is for external use only. It is not for ophthalmic, oral, anal or intravaginal use. Contact with eyes, lips and all mucous membranes should be avoided. U40 Foam should not be used by persons who have a known hypersensitivity to urea or any of the other listed ingredients.

PRECAUTIONS

U40 Foam should only be used as directed by a physician and should not be used to treat any condition other than that for which it is prescribed. If redness or irritation occurs, discontinue use and consult with prescribing physician.

Pregnancy (Category C): Animal reproduction studies have not been performed with topically applied urea and it is not known whether U40 Foam can cause fetal harm when administered to pregnant women. U40 Foam should be used by pregnant women, only under a physician’s recommendation.

Nursing Mothers: It is not known whether topically applied urea is excreted in human milk. Due to the fact that many drugs are excreted in human milk, caution should be exercised by physicians when administering U40 Foam to nursing mothers.

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

ADVERSE REACTIONS

Transient stinging, burning, itching or irritation is possible.

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

Unless otherwise directed by a prescribing physician, U40 Foam should be applied to affected area twice a day. U40 Foam should be rubbed into the skin until it is completely absorbed.

HOW SUPPLIED

U40 Foam, NDC 49769-354-75, is supplied as (2) 2.63 oz (75 g), net wt. 5.26 oz (150 g), aerosolized canisters in a carton, NDC 49769-354-15.

U40 Foam is supplied in a 2.5 oz (70 g) aerosolized canister, NDC 49769-354-70.

Store at controlled room temperature 15ºC - 25ºC (59ºF - 77ºF).

Manufactured for
Kylemore Pharmaceuticals
Port St. Joe, FL 32456
Iss. 12/09
354-10

PACKAGING:

U40 Foam (75g) labeling:

label1

U40 Foam (70g) labeling:

label2


U40 
urea aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:49769-354
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 400 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
CARBOMER 934  
OATMEAL  
DIMETHICONE  
ETHYLPARABEN  
GLYCERIN  
LAURETH-4  
METHYLPARABEN  
PHENOXYETHANOL  
POLYSORBATE 20  
PROPYLPARABEN  
PROPYLENE GLYCOL  
WATER  
STEARIC ACID  
TROLAMINE  
PROPANE  
BUTANE  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:49769-354-15 150 g in 1 CARTON None
2 NDC:49769-354-70 70 g in 1 CANISTER None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/05/2010 06/30/2012

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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