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Urea Nail Gel


Dosage Form: gel

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Urea Cream, 40% Urea Lotion, 40% Urea Gel, 40%

For External Use Only. Not For Ophthalmic Use.

Rx Only

Urea Nail Gel Description

Urea, 40% is a keratolytic emollient which is gentle, yet potent, tissue softener for nails and/or skin. Each gram of Urea Cream, 40% and Urea Lotion, 40% contains 40% urea, carbomer 940, cetyl alcohol, glyceryl monostearate, mineral oil, propylene glycol, purified water, trolamine, white petrolatum, and xanthan gum. Each gram of Urea Gel, 40% contains 40% urea, edetate disodium dihydrate, glycerin, hydroxethylcellulose, PEG-6 caprylic/capric glyceride, purified water, and xanthan gum. Urea is a diamide of carbonic acid with the following chemical structure:

Urea Nail Gel - Clinical Pharmacology

Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.

Pharmacokinetics -

The mechanism of action of topically applied urea is not yet known.


For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or prurient debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, chthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, ingrown and devitalized nails.


Known hypersensitivity to any of the listed ingredients.


For external use only. Avoid contact with eyes, lips or mucous membranes.


This medication 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.


Pregnancy category C -

Animal reproduction studies have not been conducted with urea 40%. It also is not known whether urea 40% can cause fetal harm when administered to a pregnant woman or can affect reproduction capacity. Urea 40% should be given to a pregnant woman only if clearly needed.

Nursing Mothers -

It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when Urea 40% is administered to a nursing woman.

Adverse Reactions

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

Urea Nail Gel Dosage and Administration

Apply Urea 40% to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day, or as directed by a physician.

How is Urea Nail Gel Supplied

Urea Cream, 40% is available as follows:

28.35 g tube (NDC 45802-170-03)

85 g tube (NDC 45802-170-53)

198.6 g tube (NDC 45802-170-77)

Urea Lotion, 40% is available as follows:

8 FL OZ (236.6 mL) bottle (NDC 45802-176-55)

Urea Gel, 40% is available as follows:

0.5 FL OZ (15 mL) bottle (NDC 45802-171-56)


Store at 20-25°C (68-77°F) [see USP Controlled Room Temperature].


Manufactured By Perrigo

Bronx, NY 10457

Distributed By Perrigo

Allegan, MI 49010

Rev. 02/13

: 43300 RC J3


Rx Only

Urea Gel, 40%

For External Use Only.

Not for Ophthalmic Use.

0.5 FL OZ

(15 mL)

urea gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:45802-171
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 40 g  in 100 mL
Inactive Ingredients
Ingredient Name Strength
# Item Code Package Description
1 NDC:45802-171-56 1 BOTTLE in 1 CARTON
1 15 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved drug other 06/13/2011
Labeler - Perrigo New York Inc (078846912)
Revised: 10/2014
Perrigo New York Inc