Urea, Salicylic Acid

Generic Name: urea, salicylic acid

Over-the-Counter (OTC)

Brand Names:

Urea 39.5% With 2% Salicylic Acid

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, Pol...

Overview

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, Pol...

Uses

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

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: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.

Warnings

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

Pregnancy

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.

Storage

HOW SUPPLIED Urea 39.5% Cream with 2% Salicylic Acid 8 oz. (227 g): NDC 59088-210-16

Frequently Asked Questions

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.

What are the side effects of Urea, Salicylic Acid?

ADVERSE REACTIONS: Transient stinging, burning, itching or irritation may occur and normally disappear upon discontinuing the medication.

Can I take Urea, Salicylic Acid during pregnancy?

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.

What are the important warnings for Urea, Salicylic Acid?

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

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Medical Disclaimer

This drug information is for educational purposes only and should not replace professional medical advice. Drug information is sourced from the FDA National Drug Code Directory and Structured Product Labeling. Always consult with a healthcare provider before starting, stopping, or changing any medication.