Label: UREA- urea cream
- NDC Code(s): 58980-610-30
- Packager: Stratus Pharamceuticals, Inc
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
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- SPL UNCLASSIFIED SECTION
- Active Ingredient
- Inactive Ingredients
Carbomer, Fragrance, Isopropyl Myristate, Isopropyl Palmitate, Propylene Glycol, Purified Water, Sodium Laureth Sulfate, Stearic Acid, Trolamine and Xanthan Gum.Close
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.
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.
Apply to the affected areas twice a day or as directed by a physician. Rub into the skin until completely absorbed.Close
- STORAGE AND HANDLING
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.
- PRINCIPAL DISPLAY PANEL - 85 g Label
Net WT. 3 oz. (85g)
UREA 20% CREAM
Softens and Moisturizes Severe Dry Skin
Manufactured for Stratus Pharmaceuticals Inc., 12379 SW 130th Street, Miami, Florida 33186
- INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:58980-610 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Urea (UNII: 8W8T17847W) (Urea - UNII:8W8T17847W) Urea 17 g in 85 g Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58980-610-30 1 in 1 BOX 1 85 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved other 10/31/2008 Labeler - Stratus Pharamceuticals, Inc (789001641) Establishment Name Address ID/FEI Business Operations Sonar Products, Inc 104283945 MANUFACTURE