X Viate

Stratus Pharamceuticals, Inc

X-VIATE™

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient
• Purpose
• Warnings
• Precautions
  • Pregnancy
• Directions
• Inactive Ingredients
• PRINCIPAL DISPLAY PANEL - 8.0 fl. oz. Label
• PRINCIPAL DISPLAY PANEL - 8.0 fl. oz. Box

FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Urea 40%

Purpose

Keratolytic Agent

Warnings

For external use only.

Avoid contact with eyes, lips, or mucous membranes.

Do not use:

• On areas of broken skin
• If known hypersensitivity to any of the listed ingredients.

Precautions

• Stop use and ask a doctor if redness or irritation develops.
• Keep out of the reach of children.
• If swallowed, get medical help or contact a Poison Control Center right away.

Pregnancy

• If pregnant or breast feeding, ask a health professional before use.

Directions

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

Other Information

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

Inactive Ingredients

Carbopol, Cetyl Alcohol, Glyceryl Stearate, Methyl Paraben, Mineral Oil, Propyl Paraben, Propylene Glycol, Purified Water, Trolamine, White Petrolatum and Xanthan Gum.

Manufactured by:
Sonar Products, Inc.
Carlstadt, New Jersey 07072

Exclusively for:
Stratus Pharmaceuticals Inc
12379 Southwest 130th Street
Miami, FL 33186

PRINCIPAL DISPLAY PANEL - 8.0 fl. oz. Label

NDC 58980-623-80

X-VIATE™

40 %
LOTION

Softens and
Moisturizes
Severe
Dry
Skin

Rx only

UREA 40%
IN A LOTION BASE

Distributed by:
STRATUS
PHARMACEUTICALS INC

8.0 fl. oz. (237 mL)

PRINCIPAL DISPLAY PANEL - 8.0 fl. oz. Box

NDC 58980-623-80

X-VIATE™

40 %
LOTION

Softens and
Moisturizes
Severe
Dry
Skin

Rx only

UREA 40%
IN A LOTION BASE

Distributed by:
STRATUS
PHARMACEUTICALS INC

8.0 fl. oz. (237 mL)