Urea 40% Topical Cream

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.

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

Transient stinging, burning, itching or irritation may occur and will normally disappear upon discontinuing the use of this product.

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

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:

Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

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.

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

KEEP OUT OF REACH OF CHILDREN.

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.

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.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

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.

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

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.

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.

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

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

Rx Only

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

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.

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

KEEP OUT OF REACH OF CHILDREN.

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.

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:

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.

FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.

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

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.

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

Transient stinging, burning, itching or irritation may occur and will normally disappear upon discontinuing the use of this product.

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

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.

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.

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.

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

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