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


50% Urea Topical Suspension

UREA  - urea suspension 
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.

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50% Urea Topical Suspension

How to properly use 50% Urea Topical Suspension:

Easy steps to treat dry skin conditions including
psoriasis, xerosis, ichthyosis, keratosis pilaris,
keratosis palmaris, keratoderma, dermatitis,
pruritus, eczema, corns and calluses.

For skin:
1. Apply 50% Urea Topical Suspension to
affected skin twice per day or as directed
by a physician.

2. Rub in until completely absorbed.

For external use only. Not for ophthalmic use.

DESCRIPTION:

Each gram of 50% Urea
Topical Suspension
contains: Urea 50%,
Caprylic/Capric Triglyceride, Carbomer, Cetyl
Alcohol, Disodium EDTA, Glycerin,
Hydroxyethylcellulose, Lactic Acid, Linoleic Acid,
PEG-6, Polysorbate 60, Propylene Glycol, Water,
Salicylic Acid, Sorbitan Stearate, Titanium
Dioxide, Triethanolamine, Tocopheryl Acetate,
Xanthan Gum.

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

     NH2
        |
     C=O
        |
     NH2

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.

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.

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 reproduction studies are
not always predictive of human response, 50%
UREA TOPICAL SUSPENSION
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 Topical
Suspension
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 TOPICAL SUSPENSION
to affected skin
twice per day, or as directed by a physician.
Rub in until completely absorbed.

HOW SUPPLIED:

50% UREA TOPICAL SUSPENSION is supplied
as a 284 g (10 oz) tube, NDC 68032-261-13
Store at controlled room temperature 15°-30° C
(59°-86° F).

Protect from freezing.

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

Iss. 02/09

261-12

PACKAGING

The packaging below represents the labeling currently used.

50% Urea Topical Suspension

DIRECTIONS: For use on rough, dry skin conditions.
See carton or package insert for instructions. Use only
as directed by a physician.

INGREDIENTS: Each gram of 50% Urea Topical
Suspension contains: Urea 50%, Caprylic/Capric
Triglyceride, Carbomer, Cetyl Alcohol, Disodium EDTA,
Glycerin, Hydroxyethylcellulose, Lactic Acid, Linoleic
Acid, PEG-6, Polysorbate 60, Propylene Glycol, Water,
Salicylic Acid, Sorbitan Stearate, Titanium Dioxide,
Triethanolamine, Tocopheryl Acetate, Xanthan Gum.

FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.

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

Store at controlled room temperature 15ºC to 30ºC
(59ºF to 86ºF). Protect from freezing.

For control number and expiration date, see crimp of tube.
Manufactured for:
River's Edge Pharmaceuticals, LLC
Suwanee, GA 30024
Iss. 12/08 261-22

PACKAGING1


UREA 
50% urea topical suspension suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:68032-261
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Urea (Urea) Urea 142 g  in 284 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68032-261-13 284 g in 1 TUBE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved other 02/17/2009

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

Revised: 10/2009 River's Edge Pharmaceuticals, LLC



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


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