Urea, Salicylic Acid
FDA Drug Information • Also known as: Urea 39.5% With 2% Salicylic Acid
- Brand Names
- Urea 39.5% With 2% Salicylic Acid
- Route
- TOPICAL
- Dosage Form
- CREAM
- Product Type
- HUMAN PRESCRIPTION DRUG
Description
DESCRIPTION Urea 39.5% Cream with 2% Salicylic Acid is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin space. Each gram contains 395 mg of urea, 20 mg of Salicylic Acid in vehicle consisting of: Aqua (Purified Water), Butylene Glycol, Butyrospermum Parkii (Shea) Butter, Caprylic/Capric Triglyceride, Cetearyl Alcohol, Dimethicone, Disodium EDTA, Hydroxyethyl Acrylate/Sodium Acryloyldimethyl Taurate Copolymer, Methylparaben, Mineral Oil, Petrolatum, Polysorbate 60, Propylparaben, Simethicone, Sodium Hydroxide, Squalane, Stearic Acid. Urea is a diamide of carbonic acid with the following chemical structure: Chemical Structure
What Is Urea, Salicylic Acid Used For?
INDICATIONS & USAGE 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 eshar. Urea is useful for the treatment of hyperkeratotic conditions such as dermatitis, psoriasis, soothes rough and dry skin, 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 Urea 39.5% Cream with 2% Salicylic Acid to affected skin twice per day, or as directed by your physician. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a physician.
Side Effects (Adverse Reactions)
ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.
Warnings and Precautions
WARNINGS FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP OUT OF REACH OF CHILDREN. Avoid contact with eyes, lips and mucous membranes.When using this product skin irritation and dryness is more likely to occur. 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 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.
Contraindications
CONTRAINDICATIONS This product is contraindicated in persons with known or suspected hypersensitivity to any of the ingredients of the product.
Pregnancy and Breastfeeding
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.
How Supplied
HOW SUPPLIED Urea 39.5% Cream with 2% Salicylic Acid 8 oz. (227 g): NDC 59088-210-16
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.