UREA- urea lotion 
Stratus Pharmaceuticals, 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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UREA 10%
LOTION

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

PRINCIPAL DISPLAY PANEL - 466.7g Bottle Carton
UREA 
urea lotion
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-608
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Urea (UNII: 8W8T17847W) (Urea - UNII:8W8T17847W) Urea 1 mL  in 10 mL
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:58980-608-80 1 in 1 BOX
1 236.56 mL in 1 BOTTLE
2 NDC:58980-608-60 1 in 1 BOX
2 177.42 mL in 1 BOTTLE
3 NDC:58980-608-90 1 in 1 BOX
3 473.12 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 05/20/2010
Labeler - Stratus Pharmaceuticals, Inc (789001641)
Establishment
Name Address ID/FEI Business Operations
Sonar Products, Inc 104283945 MANUFACTURE

Revised: 4/2010
Document Id: b27e4171-7de6-4736-a055-54288ac64d15
Set id: eec3162d-db41-4f40-8b0c-a61ef05469af
Version: 1
Effective Time: 20100426
 
Stratus Pharmaceuticals, Inc