GORDONS UREA 40- urea ointment

GORDONS UREA 40 by

Drug Labeling and Warnings

GORDONS UREA 40 by is a Prescription medication manufactured, distributed, or labeled by Gordon Laboratories. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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.

HOW SUPPLIED

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

SPL UNCLASSIFIED SECTION

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

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

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.

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  
urea ointment

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