X VIATE- urea lotion 
Stratus Pharamceuticals, Inc

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.

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X-VIATE™

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. Label

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)

Principal Display Panel - 8.0 fl. oz. Box
X VIATE 
urea lotion
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:58980-623
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Urea (UNII: 8W8T17847W) (Urea - UNII:8W8T17847W) Urea94.8 mg  in 237 mL
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:58980-623-801 in 1 BOX09/01/200904/15/2017
1237 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other09/01/200904/15/2017
Labeler - Stratus Pharamceuticals, Inc (789001641)

Revised: 11/2017
Document Id: 0175653b-bdad-4b44-bdd8-8ec9feb20a45
Set id: f45dfdfa-9b25-494a-b558-656168c27b07
Version: 2
Effective Time: 20171129
 
Stratus Pharamceuticals, Inc