Urea by Exact-Rx, Inc. UREA gel

Urea by

Drug Labeling and Warnings

Urea by is a Prescription medication manufactured, distributed, or labeled by Exact-Rx, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

For external use only. Not for ophthalmic use.
Keep away from eyes, lips and mucous membranes.

DESCRIPTION

DESCRIPTION: UREA Nail Gel 45% is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of UREA Nail Gel 45% contains 45% Urea, camphor, edetate disodium, eucalyptus oil, hydroxyethyl cellulose, menthol, propylene glycol and purified water.

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

CLINICAL PHARMACOLOGY

CLINICAL PHARMACOLOGY: Urea gently dissolves the intracellular 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

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

INDICATIONS & USAGE

INDICATIONS AND USES: 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, keratoderma, corns and calluses, as well as damaged and ingrown nails.

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

PREGNANCY: Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproductive studies are not always predictive of human response, Urea Nail Gel 45% 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 Nail Gel 45% is administered to a nursing woman.

ADVERSE REACTIONS

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

Call your doctor for medical advice about side effects.

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION: Apply Urea Nail Gel 45% to diseased or damaged nail tissue twice per day, or as directed by a physician.

INSTRUCTIONS FOR USE

DIRECTIONS FOR SKIN: Apply Urea Nail Gel 45% to affected area(s) twice per day, or as directed by a physician. Rub in until gel is absorbed.

HOW SUPPLIED:

Urea Nail Gel 45% is supplied in a 28 mL glass bottle NDC: 42808-0204-28.

Store at controlled room temperature 15 to 30°C (59 to 86°F). Protect from freezing.

Manufactured in the U.S.A. for Exact-Rx, Inc., Melville, NY 11747

00-0204-28-205-00

Iss:7/11

PRINCIPAL DISPLAY PANEL

For External Use Only

NDC: 42808-0204-28        Rx Only

Urea
In a vehicle containing
menthol, camphor &
eucalyptus oil

45%

NAIL GEL

Exact-Rx.
INCORPORATED

Net Wt. 28 mL

INGREDIENTS AND APPEARANCE

UREA 
urea gel

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 42808-204
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W)	UREA	450 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)
EDETATE DISODIUM (UNII: 7FLD91C86K)
EUCALYPTUS OIL (UNII: 2R04ONI662)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
MENTHOL (UNII: L7T10EIP3A)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42808-204-28	1 in 1 CARTON	08/01/2011
1		28 mL in 1 BOTTLE, GLASS; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		08/01/2011

Labeler - Exact-Rx, Inc. (137953498)

Establishment
Name	Address	ID/FEI	Business Operations
Monarch PCM, LLC		080000294	manufacture(42808-204)

Establishment
Name	Address	ID/FEI	Business Operations
Exact-Rx, Inc.		137953498	repack(42808-204)