Label: UREA 47- urea cream
- NDC Code(s): 58657-488-05
- Packager: Method Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated February 17, 2020
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- SPL UNCLASSIFIED SECTION
- CLINICAL PHARMACOLOGY:
- INDICATIONS AND USAGE:
FOR EXTERNAL USE ONLY. NOT FOR OPHTHALMIC USE.
This product is to be used as directed by a physician and should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use and consult a physician.
Information for Patients:
Patients should discontinue the use of this product if the condition becomes worse or if a rash develops in the area being treated or elsewhere. Avoid contact with eyes, lips and mucous membranes.
Carcinogenesis, Mutagenesis and Impairment of Fertility:
Long-term animal studies for carcinogenic potential have not been performed on this product to date. Studies on reproduction and fertility also have not been performed.
Category C. Animal reproduction studies have not been conducted with this product. It is also not known whether this product can affect reproduction capacity or cause fetal harm when administered to a pregnant woman. This product should be used by a pregnant woman only if clearly needed or when potential benefits outweigh potential hazards to the fetus.
- ADVERSE REACTIONS:
- DOSAGE AND ADMINISTRATION:
Store at 20°C to 25°C (68°F to 77°F), excursions permitted between 15°C to 30°C (between 59°F to 86°F). Brief exposure to temperatures up to 40°C (104°F) may be tolerated provided the mean kinetic temperature does not exceed 25°C (77°F); however, such exposure should be minimized.
NOTICE: Protect from freezing and excessive heat. Keep bottle tightly closed.
- HOW SUPPLIED:
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:58657-488 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 470 mg in 1 g Inactive Ingredients Ingredient Name Strength HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP) CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET) EDETIC ACID (UNII: 9G34HU7RV0) ALCOHOL (UNII: 3K9958V90M) EUCALYPTUS OIL (UNII: 2R04ONI662) MENTHOL (UNII: L7T10EIP3A) WATER (UNII: 059QF0KO0R) SODIUM HYDROXIDE (UNII: 55X04QC32I) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58657-488-05 142 g in 1 BOTTLE; Type 0: Not a Combination Product 08/03/2018 02/29/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 08/03/2018 02/29/2020 Labeler - Method Pharmaceuticals, LLC (060216698)