Label: RYNODERM- urea cream
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Contains inactivated NDC Code(s)
NDC Code(s): 70350-2626-1 - Packager: SOLUTECH 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.
Drug Label Information
Updated October 27, 2017
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
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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
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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.
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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
- Warnings
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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.
- Adverse Reactions
- RYNODERM - Dosage and Administration
- How is RYNODERM Supplied
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 142 gm Tube Label
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INGREDIENTS AND APPEARANCE
RYNODERM
urea creamProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:70350-2626 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W) UREA 375 mg in 1 g Inactive Ingredients Ingredient Name Strength MINERAL OIL (UNII: T5L8T28FGP) STEARIC ACID (UNII: 4ELV7Z65AP) WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 20 (UNII: 7T1F30V5YH) SODIUM ACRYLOYLDIMETHYLTAURATE-ACRYLAMIDE COPOLYMER (1:1; 90000-150000 MPA.S) (UNII: 5F4963KLHS) PHENOXYETHANOL (UNII: HIE492ZZ3T) .ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70350-2626-1 142 g in 1 TUBE; Type 0: Not a Combination Product 10/27/2017 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)
