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Urea

Stratus Pharamceuticals, Inc

UREA 20% CREAM


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active Ingredient

Urea 20%

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 controlled room temperature 15° - 30°C (59° - 86°F). Protect from Freezing. SEE PACKAGE INSERT FOR FULL PRESCRIBING INFORMATION. See Crimp and end of carton for Lot Number and Expiration Date.

UC20(3)-200907

PRINCIPAL DISPLAY PANEL - 85 g Label

NDC 58980-610-30
Net WT. 3 oz. (85g)

UREA 20% CREAM
STRATUS

PHARMACEUTICALS INC

Softens and Moisturizes Severe Dry Skin

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

Urea

Urea

Urea CREAM

Product Information

Product Type Human otc drug label Item Code (Source) NDC:58980-610
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
UREA 17 g

Product Characteristics

Color
WHITE

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 85 in 1 TUBE
2 NDC:58980-610-30 1 in 1 BOX

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2008-10-31


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