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X Viate

Stratus Pharamceuticals, Inc

X-VIATE™


FULL PRESCRIBING INFORMATION: CONTENTS*




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)

X Viate

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)

X Viate

X Viate

Urea LOTION

Product Information

Product Type Human prescription drug label Item Code (Source) NDC:58980-623
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
UREA 94.8 mg

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 237 in 1 BOTTLE
2 NDC:58980-623-80 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2009-09-01


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