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Latrix

Generic Name: urea
Dosage Form: topical suspension

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.

Latrix
Topical Suspension

Rx Only

(50% Urea) In a lactic acid & salicylic acid vehicle

For external use only.
Not for ophthalmic use.

Latrix Description

Each gram of Latrix™ Topical Suspension contains: ACTIVE: 50% Urea in a topical suspension base of INACTIVES: consisting of Caprylic/Capric Triglyceride, Carbomer, Cetyl Alcohol, Edetate Disodium, Glycerin, Hydroxyethylcellulose, Lactic Acid, Linoleic Acid, PEG-6, Polysorbate 60, Propylene Glycol, Purified Water, Salicylic Acid, Sorbitan Stearate, Titanium Dioxide, Trolamine, Vitamin E and Xanthan Gum.

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

Latrix - Clinical Pharmacology

Urea gently dissolves the intercellular matrix, which results in loosening the homy 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 hyperkeratolic surface lesions, particularly where healing is retarded by local infection, necrotic tissues, fibrinour 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 then 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, Latrix™ 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 Latrix™ Topical Suspension is administered to a nursing woman.

Keep this and all other medications out of reach of children.

Adverse Reactions

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

Latrix Dosage and Administration

Apply Latrix™ Topical Suspension to the affected skin twice per day, or as directed by a physician. Rub in until completely absorbed.

How is Latrix Supplied

Latrix™ Topical Suspension (50% Urea) is supplied as:

 
284g (10oz) tube, NDC 58980-777-10

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

Distributed by:
STRATUS PHARMACEUTICALS INC
14377 SW 142ND Street, Miami, Florida 33186

LTS-JG 2008-03

PRINCIPAL DISPLAY PANEL - 284 g Carton

NDC 58980-777-10

Rx Only

Latrix™
TOPICAL SUSPENSION

(50% Urea)
In a lactic acid &
salicylic acid vehicle

For Topical Use Only

STRATUS
PHARMACEUTICALS INC

Net Wt. 10 oz (284 g)

Latrix 
urea suspension
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:58980-777
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 WHITE Score     
Shape Size
Flavor Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:58980-777-10 1 TUBE (TUBE) in 1 BOX
1 284 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved other 10/14/2008
Labeler - Stratus Pharmaceuticals, Inc (789001641)
Registrant - Sonar Products, Inc (104283945)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc 104283945 MANUFACTURE
Revised: 10/2009
 
Stratus Pharmaceuticals, Inc
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