Urea
Cream · Topical
Uses
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.
Dosage and administration
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.
Contraindications
CONTRAINDICATIONS: This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Warnings
WARNING: KEEP OUT OF REACH OF CHILDREN.
Precautions
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 mucousmembranes. Carcinogenesis, Mutagenesis and Impairment of Fertility: Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed. Pregnancy: 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.
Side effects
ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product.
Description
DESCRIPTION: Each gram contains 200 mg of urea in a vehicle consisting 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 following chemical structure: Figure 1
How supplied
HOW SUPPLIED: 3 oz. (85 g) bottles, NDC 44523-618-03 To report a serious adverse event or obtain product information, call (866) 762-2365. Manufactured for: BIOCOMP PHARMA, INC. San Antonio, TX 78230 1355 I6180R0224 logo
Storage
STORAGE: Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized. NOTICE: Protect from freezing and excessive heat. Keep bottle tightly closed.
Label text from the FDA structured product label by BioComp Pharma, Inc. (revised Jan 13, 2026). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Urea in 9 products
Urea NDC products (9)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 71399-8455 | Urea 40 g/100g Lotion | AKRON PHARMA INC | UNAPPROVED DRUG OTHER |
| 50268-872 | Urea 40 g/100g Cream | AvPAK | UNAPPROVED DRUG OTHER |
| 81542-201 | Urea 400 mg/g Lotion | Bantry Pharma, LLC | UNAPPROVED DRUG OTHER |
| 44523-617 | Urea 400 mg/g Cream | BioComp Pharma, Inc. | UNAPPROVED DRUG OTHER |
| 44523-618 | Urea 200 mg/g Cream | BioComp Pharma, Inc. | UNAPPROVED DRUG OTHER |
| 63629-2036 | Urea 39 g/100g Cream | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 63629-2040 | Urea 40 g/100g Lotion | Bryant Ranch Prepack | UNAPPROVED DRUG OTHER |
| 24470-939 | Urea 400 mg/g Cream | Cintex Services, LLC | UNAPPROVED DRUG OTHER |
| 24470-962 | Urea 400 mg/g Lotion | Cintex Services, LLC | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is Urea used for?
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,…
What are the side effects of Urea?
ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the use of this product. See the full label for the complete list.
Who makes Urea?
Urea is listed by 6 labelers in the FDA NDC directory, including AKRON PHARMA INC, AvPAK, Bantry Pharma, LLC, BioComp Pharma, Inc..