is provided with Rynoderm Generic Name: urea Dosage Form: cream Dosage Professional Reviews More 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. Rx only For external use only. Not for ophthalmic use. Rynoderm Description Rynoderm cream is a potent keratolytic emollient which is a gentle, yet potent, tissue softener for skin and/or nails. Each gram of Rynoderm Cream contains: ACTIVE: 37.5% Urea in a cream base of: INACTIVES: Mineral Oil, Stearic Acid, Water, Glycerin, Polysorbate 20, Sepigel 305, Phenoxyethanol, Acrylate Copolymer and Vitamin E CHEMISTRY Urea is a diamide of carbonic acid with the following chemical structure: Slideshow Prednisone: 12 Things You Should Know Rynoderm - Clinical Pharmacology 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. PHARMACOKINETICS The mechanism of action of topically applied urea is not yet known. INDICATIONS AND USES 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. Contraindications Rynoderm Cream is contraindicated in patients with known hypersensitivity to any of the listed ingredients. Warnings For external use only. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin. Precautions After applying this medication, wash hands and unaffected areas thoroughly. Stop use and ask a doctor if redness or irritation develops. If swallowed, get medical help or contact Poison Control Center right away. KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN. 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, Rynoderm Cream should be given to a pregnant woman only if clearly needed. NURSING MOTHERS 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 Rynoderm Cream is administered to a nursing woman. Adverse Reactions Transient stinging, burning, itching or irritation may occur and normally disappear on discontinuing the medication. Rynoderm - Dosage and Administration Apply Rynoderm 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. How is Rynoderm Supplied Rynoderm Cream (37.5% urea) is supplied in: 142g (5 oz) tube 70350-2626-1 Store at 25 C (77 F); excursion permitted to 15 C - 30 C (59 - 86 F) Protect from freezing. [See USP Controlled Room Temperature.] Manufactured for: Solutech Pharmaceuticals LLC Peoria, AZ 85345 Rx only PRINCIPAL DISPLAY PANEL - 142 gm Tube Label NDC 70350-2626-1 FOR TOPICAL USE ONLY Rynoderm UREA 37.5% CREAM Smooth Easily Spreadable Rx only Solutech PHARMACEUTICALS Net WT. 5OZ (142 gm) Rynoderm urea cream Product Information Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:70350-2626 Route of Administration TOPICAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UREA) UREA 375 mg in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL STEARIC ACID WATER GLYCERIN POLYSORBATE 20 SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) PHENOXYETHANOL .ALPHA.-TOCOPHEROL Packaging # Item Code Package Description 1 NDC:70350-2626-1 142 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 10/27/2017 Labeler - SOLUTECH PHARMACEUTICALS LLC (080040396) Revised: 10/2017 SOLUTECH PHARMACEUTICALS LLC Next User Reviews Print this page Add to My Med List More about Rynoderm (urea topical) Dosage Information 0 Reviews Add your own review/rating Drug class: topical emollients Consumer resources Professional resources Urea Solution (FDA) Other brands: Latrix , Rea Lo 40 , X-Viate , Keralac , ... +22 more Related treatment guides Dermatological Disorders Dry Skin Pityriasis rubra pilaris FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx OTC Availability Rx and/or OTC C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Drug Class Topical emollients Related Drugs topical emollients Lac-Hydrin , Eucerin , ammonium lactate topical , glycerin topical , AmLactin , Aquaphor Dry Skin Lac-Hydrin , Eucerin , ammonium lactate topical , AmLactin , Aquaphor , urea topical , CeraVe , Cetaphil Lotion , More... Dermatological Disorders triamcinolone , clobetasol topical , betamethasone , Temovate , Diprolene , Analpram-HC , Celestone , More... Pityriasis rubra pilaris urea topical , Carmol , Latrix , X-Viate , Remeven , More... Rynoderm Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first! susceptible to
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