soliciting for U40 Foam Generic Name: urea Dosage Form: aerosol, foam Side Effects Dosage Professional Reviews More 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. 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: Slideshow Seasoned Pro: Be Mindful of These Winter Health Hazards 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 15ºC - 25ºC (59ºF - 77ºF). 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 LABEL 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 Packaging # Item Code Package Description 1 NDC:49769-354-15 150 g in 1 CARTON 2 NDC:49769-354-70 70 g in 1 CANISTER 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 Next User Reviews Print this page Add to My Med List More about U40 (urea topical) Side Effects Dosage Information 0 Reviews Add your own review/rating Drug class: topical emollients Consumer resources Professional resources Urea Solution (FDA) Other brands: Latrix , Rea Lo 40 , X-Viate , Keralac , ... +22 more Related treatment guides Dermatological Disorders Dry Skin Pityriasis rubra pilaris FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical emollients Related Drugs topical emollients Lac-Hydrin , Eucerin , ammonium lactate topical , glycerin topical , AmLactin , Aquaphor Dry Skin Lac-Hydrin , Eucerin , ammonium lactate topical , AmLactin , Aquaphor , urea topical , CeraVe , Cetaphil Lotion , More... 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