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X-Viate Lotion

Generic name: urea
Dosage form: lotion
Drug class: Topical emollients

Medically reviewed by Drugs.com. Last updated on Jul 22, 2021.

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.

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)

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 (Urea) Urea 94.8 mg in 237 mL
Product Characteristics
Color WHITE Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description
1 NDC:58980-623-80 1 BOTTLE (BOTTLE) in 1 BOX
1 237 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Unapproved other 09/01/2009
Labeler - Stratus Pharamceuticals, Inc (789001641)
Establishment
Name Address ID/FEI Operations
Sonar Products, Inc 104283945 MANUFACTURE
Stratus Pharamceuticals, Inc

Medical Disclaimer