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Uramaxin Foam

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

Rx Only

In a vehicle containing Ammonium Lactate

For external use only. Not for ophthalmic use.

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.

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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.

PHARMACOKINETICS

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

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.

Contraindications

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.

Warnings

For external use only. Avoid contact with eyes, lips or mucous membranes.

Precautions

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

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.

NURSING MOTHERS

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.

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

Adverse Reactions

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

Store at room temperature 15°-25° C (59°-77° F).

Protect from freezing.

Manufactured for:

MEDIMETRIKS PHARMACEUTICALS, INC.

363 Route 46 West

Fairfield, NJ 07004-2402 USA

www.medimetriks.com

Made in Israel

Manufactured by Perrigo

Yeruham 80500, Israel

IP005-R2

Rev. 8/10

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - CARTON

Rx Only

Uramaxin™

(20% Urea) Foam

In a vehicle containing ammonium lactate

See package insert for full prescribing information

For Topical Use Only

Medimetriks Pharmaceuticals, Inc.

Uramaxin(tm) Carton

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL - CANISTER

Rx Only

Uramaxin™

(20% Urea) Foam

In a vehicle containing ammonium lactate

See package insert for full prescribing information

For Topical Use Only

Medimetriks Pharmaceuticals, Inc.

Uramaxin(tm) Canister

URAMAXIN 
urea aerosol, foam
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:43538-220
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 20 g  in 100 g
Packaging
# Item Code Package Description
1 NDC:43538-220-99 10 g in 1 CANISTER
2 NDC:43538-220-10 1 CANISTER (CANISTER) in 1 CARTON
2 100 g in 1 CANISTER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 03/13/2009
Labeler - Medimetriks Pharmaceuticals Inc (019903816)
Registrant - L Perrigo Company (006013346)
Establishment
Name Address ID/FEI Operations
Perrigo Israel Pharmaceuticals LTD 600093611 MANUFACTURE
Revised: 08/2010
 
Medimetriks Pharmaceuticals Inc
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