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Urea Gel

Pronunciation

Generic Name: urea
Dosage Form: gel

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.

Urea Gel 40%

DESCRIPTION:

Urea Gel 40% is a keratolytic emollient which is a gentle, yet potent, tissue softener for skin.

Each gram of Urea Gel 40% contains 40% urea as the active ingredient, as well as the following inactive ingredients: disodium EDTA, glycerin, hydroxyethylcellulose, PEG-6 caprylic/capric glycerides, water, and xanthan gum.

Urea is a diamide of carbonic acid with the following chemical structure:

INDICATIONS:

Urea Gel 40% is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, xerosis, ichthyosis, skin cracks and fissures, dermatitis, eczema, psoriasis, keratoses and calluses.

CONTRAINDICATIONS:

Urea Gel 40% is contraindicated for use by patients having known hypersensitivity to any component of this preparation.

CLINICAL PHARMACOLOGY:

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas of the skin.

PHARMACOKINETICS:

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

WARNINGS AND PRECAUTIONS:

FOR EXTERNAL USE ONLY.
Avoid contact with eyes, lips, and mucous membranes.

General: This product 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 and consult a physician.

Pregnancy: Pregnancy Category C.
Animal reproduction studies have not been conducted with this product. It is also not known whether this product can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. This product should be given to a pregnant woman only if clearly needed.

Nursing Mothers: It is not known whether or not this drug is excreted in human milk. In view of this and because many drugs are excreted in human milk, caution should be exercised when this product is administered to a nursing woman.

ADVERSE REACTIONS:

Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication. You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-855-899-4237.

DOSAGE AND ADMINISTRATION:

Apply to affected area(s) twice per day or as directed by a physician. Rub in until completely absorbed.

HOW SUPPLIED:

Urea Gel 40% is supplied in a 0.5 fl oz (15 mL) bottle, NDC 42792-108-15.

Store between 15°C and 30°C (between 59°F and 86°F). Protect from freezing. Keep bottle tightly closed.

KEEP OUT OF REACH OF CHILDREN.

Manufactured for:
Austin Pharmaceuticals, LLC
501 Silverside Road, PMB# 16
Wilmington, DE 19809
v1 Rev. 04/2012
UREA  
Urea Gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:42792-108
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 400 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM  
GLYCERIN  
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)  
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES  
WATER  
XANTHAN GUM  
Product Characteristics
Color white Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:42792-108-15 15 mL in 1 BOTTLE, GLASS
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 11/26/2010
Labeler - AUSTIN PHARMACEUTICALS, LLC (078398514)
Revised: 03/2013
 
AUSTIN PHARMACEUTICALS, LLC



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