Label: GORDONS UREA 40- urea ointment
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated July 16, 2010
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- HOW SUPPLIED
- SPL UNCLASSIFIED SECTION
INDICATIONS & USAGE
For loosening, debriding and avulsion of devitalized nail tissue. Apply to affected area in an apertured pad. Protect surrounding skin. Apply Urea 40% to the diseased nail surface and cover with plastic film. Anchor with adhesive tape. Cover with "finger cut" of plastic or vinyl glove and anchor with more adhesive tape. Keep dry and occlusive for 3-7 days. Cleanse, debride and reapply if necessary.
- WARNINGS AND PRECAUTIONS
SPL UNCLASSIFIED SECTION
Urea is an organic compound present in mammals. Wehn it was first synthesized from an inorganic compound in the last century. Urea is now prepared by heating Calcium Cyanamide with water under pressure. Proteolytic action on the nail plate and nail bed by its keratolytic properties, with the resulting maceration inducing an effective, painless and bloodless nail removal procedure.
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
GORDONS UREA 40
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:10481-3005 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Urea (UNII: 8W8T17847W) (Urea - UNII:8W8T17847W) Urea 0.4 g in 1 g Inactive Ingredients Ingredient Name Strength Water (UNII: 059QF0KO0R) PETROLATUM (UNII: 4T6H12BN9U) LANOLIN (UNII: 7EV65EAW6H) WHITE WAX (UNII: 7G1J5DA97F) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:10481-3005-1 30 g in 1 JAR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 07/16/2010 Labeler - Gordon Laboratories (002333847) Registrant - Gordon Laboratories (002333847) Establishment Name Address ID/FEI Business Operations Gordon Laboratories 002333847 manufacture