Urea

Stratus Pharmaceuticals, Inc

UREA 10% LOTION

FULL PRESCRIBING INFORMATION: CONTENTS*

• Active Ingredient
• Purpose
• Inactive Ingredients
• Warnings
  • Precautions
  • Pregnancy
• Directions
• PRINCIPAL DISPLAY PANEL - 466.7g Bottle Carton

FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Urea 10%

Purpose

Keratolytic

Inactive Ingredients

Carbomer, Fragrance, Isopropyl Myristate, Isopropyl Palmitate, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearic Acid, Trolamine and Xanthan Gum.

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin. Do not use if known hypersensitivity to any of the listed ingredients.

Precautions

Stop use and ask a doctor if redness or irritation develops. Keep this and all other medications out of 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 areas twice a day or as directed by a physician. Rub into the skin until completely absorbed.

Store at 25°C (77°F); excursion permitted to 15°C - 30°C (59° - 86°F). Protect from Freezing. [See USP Controlled Room Temperature].

Protect from Freezing.

See bottom of box and/or bottle for lot number and expiration date.

SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION.

Manufactured for:
Stratus Pharmaceuticals Inc.
12379 SW 130th Street
Miami, Florida 33186

Manufactured by:
Sonar Products Inc
Carlstadt, NJ 07072

PRINCIPAL DISPLAY PANEL - 466.7g Bottle Carton

NDC 58980-608-90

UREA 10%
LOTION

Softens and Moisturizes
Severe Dry Skin

Distributed by:

STRATUS
PHARMACEUTICALS INC

Net WT. 16 Fl oz