Urea Nail

UREA NAIL- urea gel
H2-Pharma, LLC

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.

Rx Only

For external use only. Not for ophthalmic use.

DESCRIPTION

45% Urea Nil Gel is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin. Each gram of 45% Urea Nail Gel contains: 45% urea. Other ingredients: camphor, disodium EDTA, eucalyptus oil, hydroxyethylcellulose, menthol, propylene glycol, and purified water.

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

Chemical StructureChemical 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. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual removal of devitalized nail plate tissue.

PHARMACOKINETICS

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

INDICATIONS AND USES

45% Urea Nail Gel is indicated for use in the topical treatment 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, devitalized and ingrown nails.

CONTRAINDICATIONS

Known hypersensitivity to any of the listed ingredients.

WARNINGS

For external use only. Avoid contact with eyes, lips or mucus membranes. Temporary stinging, burning, itching, or irritation may occur and normally disappear on discontinuation of the medication.

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. If swallowed seek medical attention or contact a Poison Control Center immediately.

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 reproductive studies are not always predictive of human response, 45% Urea Nail Gel should be given to a pregnant woman only if clearly needed.

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 45% Urea Nail Gel is administered to a nursing woman.

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

Adverse Reactions to Urea Nail

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

DOSAGE AND ADMINISTRATION

Apply 45% Urea Nail Gel to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.

HOW SUPPLIED

45% Urea Nail Gel is supplied in 28 mL bottles, NDC 61269-181-28.

Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). See USP Controlled Room Temperature.

Protect from freezing.

Manufactured for:
H2-Pharma, LLC
Montgomery, AL 36117
www.h2-pharma.com

Rev. 10/16 181-28

PRINCIPAL DISPLAY PANEL — 28 mL Bottle Carton

NDC 61269-181-28

Rx Only

45% Urea Nail Gel

In a vehicle containing
Camphor, Eucalyptus Oil and Menthol

FOR TOPICAL USE ONLY

28 mL Bottle
with Applicator Brush

H2 pharma

PRINCIPAL DISPLAY PANEL -- 28 mL Bottle Carton
(click image for full-size original)
UREA NAIL
urea gel
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:61269-181
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 450 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
CAMPHOR (SYNTHETIC)
EDETATE DISODIUM
EUCALYPTUS OIL
HYDROXYETHYL CELLULOSE (4000 MPA.S AT 1%)
MENTHOL, UNSPECIFIED FORM
PROPYLENE GLYCOL
WATER
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:61269-181-28 28 mL in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 02/20/2017
Labeler — H2-Pharma, LLC (028473634)

Revised: 03/2017 H2-Pharma, LLC

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