Urea 20%

Generic Name: urea 20%

Over-the-Counter (OTC)

Brand Names:

Uracin 20%

DESCRIPTION Uracin 20% Cream is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 200 mg of urea in a vehicle consisting of the following inactive ingredients : Aqua (Purified Water), Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Laureth-7, PEG-100 S...

Overview

DESCRIPTION Uracin 20% Cream is a keratolytic emollient which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram contains 200 mg of urea in a vehicle consisting of the following inactive ingredients : Aqua (Purified Water), Butyrospermum Parkii (Shea) Butter, C13-14 Isoparaffin, Ceteareth-20, Cetearyl Alcohol, Citric Acid, Cocos Nucifera (Coconut) Oil, Dimethicone, Ethylhexylglycerin, Glycerin, Glyceryl Stearate, Helianthus Annuus (Sunflower) Seed Oil, Laureth-7, PEG-100 S...

Uses

INDICATIONS AND 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 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. Soothes rough and dry skin.

Dosage

DOSAGE AND ADMINISTRATION Apply Uracin 20% Cream to affected area twice per day, or as directed by a licensed healthcare practitioner. Rub in until completely absorbed. Apply to diseased or damaged nail(s) twice per day, or as directed by a licensed healthcare practitioner.

Side Effects

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

Warnings

WARNINGS FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes, lips and mucous membranes. General This product is to be used as directed by a licensed healthcare practitioner 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 licensed healthcare practitioner. 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 Uracin™ 20% cream is supplied in a 8 oz.(227 g) jar, NDC 59088-257-16

Frequently Asked Questions

What is Urea 20% used for?

INDICATIONS AND 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 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. Soothes rough and dry skin.

What are the side effects of Urea 20%?

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

Can I take Urea 20% 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 20%?

WARNINGS FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. If swallowed, get medical help or contact a Poison Control Center right away. Avoid contact with eyes, lips and mucous membranes. General This product is to be used as directed by a licensed healthcare practitioner 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 licensed healthcare practitioner. 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.