FDA Label for Urea 40%

Other

Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

To report SUSPECTED ADVERSE REACTIONS, contact Patrin Pharma at 1-800-936-3088 or FDA at 1-800-FDA-1088 or www. fda.gov/medwatch for voluntary reporting of suspected adverse reactions.

Made in the USA
Manufactured for:
Patrin Pharma
Skokie, IL 60076
Questions (800) 936 3088

Rev 01.0525

Description

Each gram contains 400 mg of urea in a vehicle of carbomer, cetyl alcohol, dimethyl isosorbide, glyceryl stearate, mineral oil, petrolatum, propylene glycol, purified water, sodium hydroxide, and xanthan gum.

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

Chemical Structure - urea 01

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.

Indications

For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis pilaris, keratosis palmaris, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.

Contraindications

This product is contraindicated in people with known or suspected hypersensitivity to any of the ingredients of the product.

Warning

KEEP OUT OF REACH OF CHILDREN.

Precautions

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

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.

Information For Patients

Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.

Carcinogenesis, Mutagenesis And Impairment Of Fertility

Long-term animal studies for carcinogenic potential have not been performed on this product. Studies on reproduction and fertility also have not been performed.

Category C

Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.

Nursing Mothers

It is not known whether this drug is excreted in human milk. 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 will normally disappear upon discontinuing the use of this product.

Dosage And Administration

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

Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.

Storage

Store at 20–25°C (68–77°F), excursions permitted to 15–30°C (59–86°F). Protect from freezing and excessive heat. Keep bottle tightly closed

How Supplied

28.35 g (1 oz.) bottles, NDC 39328-019-01

85 g (3 oz.) bottles, NDC 39328-019-03

198.4 g (7 oz.) bottles, NDC 39328-019-07

Principal Display Panel - 28.35 G Bottle Carton

NDC 39328-019-01

Urea 40%
Topical Cream

For External Use Only
Not for Ophthalmic Use

Rx Only

Net Wt.
28.35 g (1 oz.)

PATRIN
PHARMA

Chemical Structure - urea 02