Generic Name: urea
Dosage Form: foam
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.
Uramaxin™ (20% Urea) Foam
Uramaxin Foam Description
Uramaxin™ (20% Urea) Foam is a keratolytic emollient moisturizer. Each gram contains 20% urea, purified water, ammonium lactate, white petrolatum, octyl palmitate, caprylic/capric triglyceride, hydrogenated polyisobutene, propylene glycol, rice starch, polysorbate 60, cyclomethicone, glyceryl stearate & PEG-100 stearate, cetearyl alcohol & cetearyl glucoside, polysorbate-20, phenoxyethanol, cetyl alcohol, dimethicone, potassium sorbate, allantoin, tocopheryl acetate, xanthan gum. In propellants isobutane & propane & butane.
Urea is a diamide of carbonic acid with the following chemical structure:
Uramaxin Foam - Clinical Pharmacology
Urea gently lyses/dissolves the intercellular matrix of surface skin cells loosening and allowing a shedding of rough, thickened and scaly hyperkeratotic skin. Urea also moisturizes and softens skin.
INDICATIONS AND USES
For softening, smoothing and removing rough scaling hyperkeratotic skin in conditions such as xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.
Known hypersensitivity to any of the listed ingredients. Discontinue if hypersensitivity is observed. Sun exposure to areas of skin treated with Uramaxin™ (20% Urea) Foam should be minimized or avoided.
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 Category C
Animal reproduction studies have not been conducted with Uramaxin™ (20% Urea) Foam. It is also not known whether Uramaxin™ (20% Urea) Foam can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Uramaxin™ (20% Urea) Foam should be given to a pregnant woman only if clearly needed.
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 Uramaxin™ (20% Urea) Foam is administered to a nursing woman.
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
Uramaxin Foam Dosage and Administration
Apply Uramaxin™ (20% Urea) Foam to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.
How is Uramaxin Foam Supplied
Uramaxin™ (20% Urea) Foam is supplied in a 100 g (3.5 oz.) canister, NDC 43538-220-10
MEDIMETRIKS PHARMACEUTICALS, INC.
363 Route 46 West
Fairfield, NJ 07004-2402 USA
Made in Israel
Manufactured by Perrigo
Yeruham 80500, Israel
PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - CARTON
(20% Urea) Foam
In a vehicle containing ammonium lactate
See package insert for full prescribing information
For Topical Use Only
Medimetriks Pharmaceuticals, Inc.
urea aerosol, foam
|Labeler - Medimetriks Pharmaceuticals Inc (019903816)|
|Registrant - L Perrigo Company (006013346)|
|Perrigo Israel Pharmaceuticals LTD||600093611||MANUFACTURE|