You are here: Home > Prescription(RX) Drugs > U > Urea (River's Edge Pharmaceuticals, Llc)

Name:Urea
Manufacturer:River's Edge Pharmaceuticals, Llc
Category:Prescription Marketed Drugs


50% Urea Nail Stick

UREA  - urea stick 
River's Edge Pharmaceuticals, 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.

----------

50% Urea Nail Stick

DESCRIPTION:

River’s Edge 50% Urea Nail Stick is a keratolytic solution, which is a gentle, yet potent, tissue softener for nails. Each mL of River’s Edge 50% Urea Nail Stick contains 50% Urea, Disodium EDTA, Hydroxyethylcellulose, Lactic Acid, Propylene Glycol, Purified Water, Triethanolamine, Xanthan Gum and Zinc Pyrithione.

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, 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, River’s Edge 50% Urea Nail Stick 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 River’s Edge 50% Urea Nail Stick 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.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

DOSAGE AND ADMINISTRATION:

Apply River’s Edge 50% Urea Nail Stick to diseased or damaged nail tissue twice per day, or as directed by a physician.

HOW SUPPLIED:

River’s Edge 50% Urea Nail Stick, NDC 68032-131-06, is supplied in a carton containing 6 NAILSTICKS (2.4 mL each).

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

Manufactured for:
River's Edge Pharmaceuticals, LLC
Suwanee, GA 30024

Rev. 09/09
131-12

PACKAGING:

label

UREA 
urea stick
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-131
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
UREA (UREA) UREA 500 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
EDETATE DISODIUM  
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)  
LACTIC ACID  
PROPYLENE GLYCOL  
WATER  
TROLAMINE  
XANTHAN GUM  
PYRITHIONE ZINC  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-131-06 2.4 mL in 1 APPLICATOR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/25/2006 10/31/2012

Labeler - River's Edge Pharmaceuticals, LLC (133879135)

Revised: 12/2010 River's Edge Pharmaceuticals, LLC



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


Copyright © 2017 Drugsdb.eu by Dionisios Fentas || Terms of Use

Loading

Prescription Marketed Drugs Alphabetically
A| B| C| D| E| F| G| H| I| J| K| L| M| N| O| P| Q| R| S| T| U| V| W| X| Y| Z| 0-9

Categories:
Prescription(RX) Drugs
Over-the-counter (OTC) Drugs
Homeopathic Drugs
Animal Drugs
Feedback