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Name:Urea Solution 50%
Manufacturer:E. Fougera & Co. A Division Of Nycomed Us Inc.
Category:Prescription Marketed Drugs


50% UREAPre-filled applicator

UREA  SOLUTION 50% - urea solution 
E. FOUGERA & CO. A division of Nycomed US Inc.

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.

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50% UREA
Pre-filled applicator

For external use only. Not for ophthalmic use.

DESCRIPTION

50% Urea Pre-filled applicator contains a keratolytic solution, which is a gentle, yet potent, tissue softener for nails and skin. Each mL contains 50% urea in a formulation consisting of: caprylic/capric triglyceride, disodium EDTA, hydroxyethylcellulose, lactic acid, PEG-6, polysorbate 60, propylene glycol, purified water sorbitan stearate, titanium dioxide, triethanolamine, urea, vitamin E, xanthan gum and zinc undecylenate.

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

Chemical Stucture

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.

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 pilaris, keratosis palmaris, 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 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 reproductive studies are not always predictive of human response, 50% Urea solution 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 50% Urea solution 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 50% Urea solution to diseased or damaged nail tissue twice per day, or as directed by a physician.

HOW SUPPLIED

50% Urea Pre-filled applicator

NDC 0168-0644-12, is supplied in a carton containing 1 -12 mL applicator.

Store at controlled room temperature 15˚- 30˚C (59˚-86˚F).

Protect from freezing.

Manufactured for:
E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

Manufactured by:
Pegasus Laboratories, Inc.
Pensacola, FL 32514

IL352B

R6/08

PATIENT INSTRUCTIONS

fougera®
50% UREA
Pre-filled applicator

HOW TO USE

  1. Remove cap and twist top of applicator to right to open and unlock. Twist bottom dial to release medication. Note: When using for the first time, it will take a number of turns of the dial before solution appears.
  2. Using the sponge tip, apply a thin layer of 50% Urea solution to the surface of the nail(s) or skin as directed by physician.
  3. WARNING: Avoid contact with eyes, lips or mucous membranes.
  4. Replace cap immediately to prevent sponge applicator from drying out.
    Twist Dial
    Apply Sponge Tip

Please see reverse side for full Prescribing Information.

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 12 ML LABEL

NDC 0168-0644-12

12 mL

Fougera

Rx only

50% UREA
Pre-filled applicator

FOR EXTERNAL USE ONLY. AVOID CONTACT
WITH EYES, LIPS OR MUCOUS MEMBRANES.
KEEP OUT OF REACH OF CHILDREN.
KEEP CONTAINER TIGHTLY CLOSED.

DIRECTIONS: Apply 50% Urea solution to diseased or damaged nail or skin tissue twice a day, or as directed by a physician.

Mfd for: E. FOUGERA & CO.,
A division of Nycomed US Inc., Melville New York 11747
Mfd. by: Pegasus Laboratories, Inc., Pensacola, FL 32514

Label

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – 12 ML CARTON

NDC 0168-0644-12

Fougera

50% UREA
Pre-filled applicator

FOR EXTERNAL USE ONLY.
AVOID CONTACT WITH EYES,
LIPS OR MUCOUS MEMBRANES.
KEEP OUT OF REACH OF CHILDREN

Rx only

12 mL

E. FOUGERA & CO.
A division of Nycomed US Inc.
Melville, New York 11747

Carton

UREA   SOLUTION 50%
urea solution
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0168-0644
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
urea (urea) urea 1 g  in 1 mL
Inactive Ingredients
Ingredient Name Strength
water  
edetate disodium  
titanium dioxide  
propylene glycol  
polysorbate 60  
xanthan gum  
sorbitan monostearate  
alpha-tocopherol  
lactic acid  
zinc undecylenate  
trolamine  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0168-0644-12 12 mL in 1 APPLICATOR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 09/17/2009

Labeler - E. FOUGERA & CO. A division of Nycomed US Inc. (043838424)
Registrant - Nycomed US Inc. (043838424)

Revised: 09/2009 E. FOUGERA & CO. A division of Nycomed US Inc.



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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