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Urea

Acella Pharmaceuticals, LLC

Urea 40% Nail Filmsuspension with applicator


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

For external use only. Not for ophthalmic use.

Rx Only

Description: Urea 40% Nail Film is a keratolytic, emollient which is a gentle, yet potent, tissue softener for nails and skin.

Each gram of Urea 40% Nail Film suspension with applicator contains 40% urea, sodium hyaluronate disodium EDTA, glycerin, hydroxyethyl cellulose, PEG-6 caprylic/capric glycerides, purified water and xanthan gum.

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

Urea

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 debridement of the nail plate.

Pharmacokinetics: The mechanism of action of 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, keratoderma, corns, and calluses , as well as damaged, ingrown or devitalized nails.

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 Category C: Animal reproduction studies have not been conducted with Urea 40% Nail Film. It is also not known whether Urea 40% Nail Film can cause fetal harm when administered to a pregnant woman or can affect reproductive capacity. Urea 40% Nail Film 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 40% Nail Film is administered to a nursing woman.

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 Urea 40% Nail Film to diseased or damaged nail tissue or skin twice per day, or as directed by a physician. Cover with adhesive bandage or gauze, secure with adhesive tape. An additional option is to remove a “finger” from a plastic or vinyl glove and slip it over the bandage-covered site. Secure glove finger with additional adhesive tape.

How Supplied: Urea 40% Nail Film is supplied in a 18 mL glass bottle (NDC 42192-707-18) with an applicator brush.

Store at controlled room temperature 15° - 30°C (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
Alpharetta, GA 30022
1-800-541-4802
Rev. 0413

PRINCIPAL DISPLAY PANEL- 18 mL

NDC 42192-707-18

Urea 40% Nail Film
suspension with appicator

For Topical Use Only
Not for Ophthalmic Use

Rx Only

Net Wt 18 mL

Acella
PHARMACEUTICALS, LLC

Urea

Urea

Urea SOLUTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:42192-707
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
UREA 400 mg

Inactive Ingredients

Ingredient Name Strength
HYALURONATE SODIUM
EDETATE DISODIUM
GLYCERIN
HYDROXYETHYL CELLULOSE (6500 MPA.S AT 2%)
PEG-6 CAPRYLIC/CAPRIC GLYCERIDES
water
XANTHAN GUM

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 18 in 1 BOTTLE, WITH APPLICATOR
2 NDC:42192-707-18 1 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2009-06-22


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