Stratus Pharamceuticals, Inc
For external use only.
Not for ophthalmic use.
REMEVEN™ CREAM is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails.
Each gram of REMEVEN™ CREAM contains:
ACTIVE: 50% Urea in a cream base of:
INACTIVES:Acrylates Copolymer, Carbomer, dl - Alphatocopheryl Acetate, Disodium EDTA, Glycerine, Lactic Acid, Mineral Oil, Polysorbate 85, Purified Water, Sodium Hydroxide, Stearic Acid and Zinc Pyrithione.
Urea is a diamide of carbonic acid with the following chemical structure:
Urea gently dissolves the intercellular matrix which results in loosening the horny layer of skin and shedding scaly skin at regular intervals, thereby softening hyperkeratotic areas. Urea also hydrates and gently dissolves the intercellular matrix of the nail plate, which can result in the softening and eventual debridement of the nail plate.
The mechanism of action of topically applied Urea is not yet known.
For debridement and promotion of normal healing of hyperkeratotic surface lesions, particularly where healing is retarded by local infection, necrotic tissue, fibrinous or prurient 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, ingrown and devitalized nails.
Known hypersensitivity to any of the listed ingredients.
For external use only. Avoid contact with eyes, lips or mucous membranes.
If redness or irritation occurs, discontinue use. After applying this medication, wash hands and unaffected areas thoroughly. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.
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, REMEVEN™ CREAM should be given to a pregnant woman only if clearly needed.
It is not known whether or not this drug is secreted in human milk. Because many drugs are secreted in human milk, caution should be exercised when REMEVEN™ CREAM is administered to a nursing woman.
Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication.
Apply REMEVEN™ CREAM to affected skin twice per day or as directed by a physician. Rub in until completely absorbed. Apply to diseased or damaged nail tissue twice per day or as directed by a physician.
REMEVEN™ CREAM (50% Urea) is supplied in:
|142g (5 oz) tube||58980-680-50|
|255g (9 oz) tube||58980-680-90|
Store at controlled room temperature 15°-30°C (59°-86°F). Protect from freezing.
Stratus Pharmaceuticals Inc,
Miami, Florida 33186-6727
Sonar Products, Inc., Carlstadt, NJ 07072
NET WT 5.0 oz (142g)
(50% UREA IN A CREAM BASE)
Manufactured for Stratus Pharmaceuticals Inc., 14377 SW 142nd Street, Miami, Florida 33186
|Marketing Category||Application Number or Monograph Citation||Marketing Start Date||Marketing End Date|
|UNAPPROVED DRUG OTHER||06/18/2008|
|Labeler - Stratus Pharamceuticals, Inc (789001641)|
|Registrant - Sonar Products, Inc (104283945)|
|Sonar Products, Inc||104283945||MANUFACTURE|