UREA

Acella Pharmaceuticals

50% UREA EMULSION

FULL PRESCRIBING 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:

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.

PHARMACOKINETICS: The mechanism of action of the topically applied Urea is not yet known.

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.

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

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

PRECAUTIONS: 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: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus; however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, 50% Urea Emulsion should be given to a pregnant woman only if clearly needed.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

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

DOSAGE AND ADMINISTRATION: Apply 50% Urea Emulsion to affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.

HOW SUPPLIED: 50% Urea Emulsion is supplied in a 10 oz. tube (NDC 42192-101-10). Store at controlled room temperature, 15° - 30° (59° - 86°F). Protect from freezing.

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
1-800-541-4802

NDC 42192-101-10

50% Urea
Emulsion
In a zinc undecylenate and lactic acid vehicle

Rx Only
Net Weight 10 oz
For Topical Use Only

Indications: For use on rough dry skin
conditions. See carton or package insert for
instructions.

USE ONLY AS DIRECTED BY A
PHYSICIAN.

Ingredients: Each gram of 50% Urea
Emulsion contains 50% urea in a formulation
consisting of caprylic or 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.

KEEP THIS AND ALL MEDICATIONS OUT
OF THE REACH OF CHILDREN.
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

Storage: Store at controlled room temperature
15 - 30C (59 - 86F) Protect from
freezing.

For lot number and expiration date, see
crimp of tube.

All prescription substitutions using this
product shall be made subject to state and
federal statutes as applicable. Note: This is
not an Orange Book product. Please see
insert for further details.

Manufactured for:
Acella Pharmaceuticals
9005 Westside Parkway
Alpharetta, GA 30009
1-800-541-4802