RE-U40 Foam

RE-U40 Foam Description

RE-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.

RE-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.

RE-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 RE-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.

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Warnings

RE-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. RE-U40 Foam should not be used by persons who have a known hypersensitivity to urea or any of the other listed ingredients.

Precautions

RE-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 RE-U40 Foam can cause fetal harm when administered to pregnant women. RE-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 RE-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.

RE-U40 Foam Dosage and Administration

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

How is RE-U40 Foam Supplied

RE-U40 Foam, NDC 68032-354-75, is supplied as (2) 2.63 oz (75 g), net wt. 5.26 oz (150 g), aerosolized canisters in a carton, NDC 68032-354-15.

Manufactured for
River’s Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Iss. 02/09
354-11

PACKAGING