GORDONS UREA 40  - urea ointment 
Gordon Laboratories

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.

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GORDONS UREA 40

Urea 40% has been used for many years for the nonsurgical avulsion of mycotic nails. Nonsurgical avulsion is a conservative procedure which can be utilized by the geriatric, diabetic or vascular patient. Nonsurgical avulsion has the advantage of avoiding the possible side effects of oral drugs.


Gordon's Urea 40% is supplied as 1 oz. Jars.

Urea 40%, Petrolatum 17.8%, White Wax 5%, Anhydrous Lanolin 15%, Purified Water

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.


Hypersensitivity to Urea or any of the components of this preparation. If redness or irritation occurs, discontinue use. For external use only. Keep out of reach of children.

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.

Image of Urea 40 Label

GORDONS UREA 40  
urea ointment
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:10481-3005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Urea (UNII: 8W8T17847W) (Urea - UNII:8W8T17847W) Urea0.4 g  in 1 g
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
PETROLATUM (UNII: 4T6H12BN9U)  
LANOLIN (UNII: 7EV65EAW6H)  
WHITE WAX (UNII: 7G1J5DA97F)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:10481-3005-130 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other07/16/2010
Labeler - Gordon Laboratories (002333847)
Registrant - Gordon Laboratories (002333847)
Establishment
NameAddressID/FEIBusiness Operations
Gordon Laboratories002333847manufacture

Revised: 7/2010
Document Id: 9d73475d-b995-402e-b64e-3811735604bb
Set id: f0b2b115-653c-4b3d-96ff-df94bd0d25bb
Version: 3
Effective Time: 20100716
 
Gordon Laboratories