Latrix

Stratus Pharmaceuticals, Inc
Sonar Products, Inc

LATRIXTopical Suspension

FULL PRESCRIBING INFORMATION: CONTENTS*

• LATRIX DESCRIPTION
• CLINICAL PHARMACOLOGY
  • PHARMACOKINETICS
• INDICATIONS AND USES
• LATRIX CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • PREGNANCY
  • NURSING MOTHERS
• LATRIX ADVERSE REACTIONS
• LATRIX DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 284 g Carton

FULL PRESCRIBING INFORMATION

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.

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

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.

LATRIX 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.

LATRIX 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 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)