Drugplain

Uracin 20% .2 g/g

Urea 20% · CREAM · PureTek Corporation

No Recall History
Plain English

Uracin 20% is a cream containing urea 20% at .2 g/g, taken topical. Manufactured by PureTek Corporation.

Key Facts

Brand Name
Uracin 20%
Generic Name
Urea 20%
NDC Code (Product)
59088-257
Manufacturer
PureTek Corporation
Strength
.2 g/g
Dosage Form
CREAM
Route
TOPICAL
Marketing Status
Marketing Start
02/20/2026

Recall History

No Recall History

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

death3 reports
diarrhoea2 reports
myocardial infarction2 reports
abdominal discomfort1 reports
application site pain1 reports
application site swelling1 reports
cellulitis1 reports
condition aggravated1 reports
disease progression1 reports
drug ineffective1 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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 & Administration

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.

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. 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

Contraindications

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

Adverse Reactions

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

Frequently Asked Questions

What is Uracin 20% used for?

Uracin 20% contains Urea 20%. It is a cream taken topical. Consult your doctor for specific uses.

Is Uracin 20% a controlled substance?

Uracin 20% is not classified as a controlled substance by the DEA.

What is the generic name for Uracin 20%?

The generic name for Uracin 20% is Urea 20%. There are 1 other brand versions of Urea 20%.

What is the NDC code for Uracin 20% .2 g/g?

The NDC (National Drug Code) for Uracin 20% .2 g/g is 59088-257, listed by PureTek Corporation.

Product NDC

59088-257

Package NDC

59088-257-16

Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)