UREA - urea cream
River's Edge Pharmaceuticals, LLC
----------Urea 45% Cream
Urea 45% Cream is indicated for the debridement and promotion of the normal healing of hyperkeratotic surface lesions, particularly where healing is delayed by local infection, necrotic tissue, fibrinous or purulent debris or eschar. Urea is useful for the treatment of hyperkeratotic conditions such as dry, rough skin, dermatitis, psoriasis, xerosis, ichthyosis, eczema, keratosis, keratoderma, corns and calluses, as well as damaged, devitalized and ingrown nails.
DIRECTIONS: Apply RIVER’S EDGE Urea 45% Cream to damaged nail tissue or affected skin area(s) twice a day or as directed by a physician.
45% Urea/g cream topical preparation
Known hypersensitivity or intolerance to any component of this product.
KEEP OUT OF REACH OF CHILDREN.
5.1 General: For external use only. Avoid contact with eyes, lips or mucous membranes. If swallowed seek medical attention or contact a Poison Control Center immediately.
5.2 Information for the Patient: Use this medication only as directed by a physician. It should not be used to treat any condition other than that for which it was prescribed. If redness or irritation occurs, discontinue use.
8.1 Pregnancy Pregnancy Category B. Animal reproduction studies have revealed no evidence of harm to the fetus, however, there are no adequate and well-controlled studies in pregnant women. Because animal reproduction studies are not always predictive of human response, Urea 45% Cream should be given to a pregnant woman only if clearly needed.
8.3 Nursing Mothers It is not known whether or not this drug is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Urea 45% Cream is administered to a nursing woman.
Urea 45% Cream is a keratolytic emollient, which is a gentle, yet potent, tissue softener for nails and/or skin.
Each gram of Urea 45% Cream contains 45% Urea. Other ingredients: Camphor, Edetate Disodium, Ethyl Alcohol SD 40 B, Eucalyptus Oil, Hydroxyethyl Cellulose, Menthol, Purified Water, Titanium Dioxide, Sodium Hydroxide 50% Solution.
Urea is a diamide of carbonic acid with the following chemical structure:
Urea 45% Cream Labeling:
Urea 45% Cream Carton:
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|unapproved drug other||02/20/2010|
|Labeler - River's Edge Pharmaceuticals, LLC (133879135)|