UREA by ACELLA PHARMACEUTICALS UREA emulsion

UREA by

Drug Labeling and Warnings

UREA by is a Prescription medication manufactured, distributed, or labeled by ACELLA PHARMACEUTICALS. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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

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

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

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.

CONTRAINDICATIONS

CONTRAINDICATIONS: Known hypersensitivity to any of the listed ingredients.

WARNINGS

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

PRECAUTIONS

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: 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.

NURSING MOTHERS

NURSING MOTHERS: It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when 50% Urea Emulsion is administered to a nursing woman

KEEP OUT OF REACH OF CHILDREN

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

ADVERSE REACTIONS

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

DOSAGE & ADMINISTRATION

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

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.

DESCRIPTION

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

DOSAGE & ADMINISTRATION

How to properly use

50% Urea

Emulsion

In a zinc undecylenate and lactic acid vehicle



Easy steps to treat dry skin conditions including psoriasis, xerosis, ichthyosis, keratosis pilaris, keratosis palmaris,

keratoderma, dermatitis, pruritus, eczema, corns and calluses.



For skin:

1. Apply 50% Urea Emulsion to affected skin twice per day, or as directed by a physician.

2. Rub in until completely absorbed (for best results apply to moistened skin).

PRINCIPAL DISPLAY PANEL

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

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UREA 
urea emulsion

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42192-101
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	50 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
TRICAPRIN (UNII: O1PB8EU98M)
CETYL ALCOHOL (UNII: 936JST6JCN)
EDETATE DISODIUM (UNII: 7FLD91C86K)
GLYCERIN (UNII: PDC6A3C0OX)
POWDERED CELLULOSE (UNII: SMD1X3XO9M)
LACTIC ACID (UNII: 33X04XA5AT)
LINOLEIC ACID (UNII: 9KJL21T0QJ)
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)
POLYSORBATE 60 (UNII: CAL22UVI4M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TROLAMINE (UNII: 9O3K93S3TK)
WATER (UNII: 059QF0KO0R)
ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)
XANTHAN GUM (UNII: TTV12P4NEE)
ZINC UNDECYLENATE (UNII: 388VZ25DUR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42192-101-10	283.5 g in 1 TUBE; Type 0: Not a Combination Product	06/29/2009

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/29/2009

Labeler - ACELLA PHARMACEUTICALS (825380939)