U
urea
Dosage Form: aerosol, foam
U40 Foam
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:
U40 Foam - 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 U40 Foam
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.
U40 Foam 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 is U40 Foam 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 15?C - 25?C (59?F - 77?F).
Manufactured for
Kylemore Pharmaceuticals
Port St. Joe, FL 32456
Iss. 12/09
354-10
PACKAGING:
U40 Foam (75g) labeling:
U40 Foam (70g) labeling:
U40
urea aerosol, foam
Product Information
Product Type
HUMAN PRESCRIPTION DRUG
NDC Product Code (Source)
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
#
NDC
Package Description
Multilevel Packaging
1
49769-354-15
150 g In 1 CARTON
None
2
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: 03/2011Kylemore Pharmaceuticals, LLC
More U40 Foam resources
U40 Foam Side Effects (in more detail)U40 Foam Use in Pregnancy & Breastfeeding0 Reviews for U40 - Add your own review/rating
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