Thursday, October 6, 2016

Gordons Urea 40




Generic Name: urea

Dosage Form: ointment
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.











Gordons Urea 40  
urea  ointment










Product Information
Product TypeHUMAN PRESCRIPTION DRUGNDC Product Code (Source)10481-3005
Route of AdministrationTOPICALDEA Schedule    








Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Urea (Urea)Urea0.4 g  in 1 g












Inactive Ingredients
Ingredient NameStrength
Water 
PETROLATUM 
LANOLIN 
WHITE WAX 


















Product Characteristics
Color    Score    
ShapeSize
FlavorImprint Code
Contains      










Packaging
#NDCPackage DescriptionMultilevel Packaging
110481-3005-130 g In 1 JARNone










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/FEIOperations
Gordon Laboratories002333847manufacture
Revised: 07/2010Gordon Laboratories




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