Urea Emulsion

Urea Emulsion

Urea Emulsion Recall

Get an alert when a recall is issued.

Questions & Answers

Side Effects & Adverse Reactions

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

Legal Issues

There is currently no legal information available for this drug.

FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.


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.


There is currently no drug history available for this drug.

Other Information

DESCRIPTION: Each gram of 50% Urea Emulsion contains 50% urea in a formulation consisting of: caprylic/capric triglyceride, cetyl alcohol, disodium EDTA, glycerin, hydroxyethyl cellulose, lactic acid, linoleic acid, PEG-6, polysorbate 60, propylene glycol, sorbitan stearate, titanium dioxide, triethanolamine, purified water, vitamin E, xanthan gum and zinc undecylenate.

Urea is a diamide of carbonic acid with the following chemical structure:

urea chemical formula

All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, incipients, inactive ingredients and chemical formulation information provided herein.

MANUFACTURED FOR: Acella Pharmaceuticals, LLC
9005 Westside Parkway
Alpharetta, GA 30009

Urea Emulsion Manufacturers

  • Acella Pharmaceuticals
    Urea Emulsion [Acella Pharmaceuticals]
  • Exact-rx, Inc.
    Urea Emulsion [Exact-rx, Inc.]

Login To Your Free Account