X-Viate Lotion

urea

Dosage Form: lotion
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. 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 NDC Product Code (Source) 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

Inactive Ingredients Ingredient Name Strength No Inactive Ingredients Found

Product Characteristics Color WHITE Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 58980-623-80 1 BOTTLE In 1 BOX contains a BOTTLE 1 237 mL In 1 BOTTLE This package is contained within the BOX (58980-623-80)

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

Revised: 08/2009Stratus Pharamceuticals, Inc

More X-Viate Lotion resources

• X-Viate Lotion Side Effects (in more detail)
• X-Viate Lotion Use in Pregnancy & Breastfeeding
• X-Viate Lotion Support Group
• 2 Reviews for X-Viate - Add your own review/rating

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