GORDONS UREA 40

Manufacturer: Gordon Laboratories
Effective date: 2010-07-16
Label type: HUMAN PRESCRIPTION DRUG LABEL
Version: 3
Source: legacy-cache
Hydrated at: 2026-08-02 01:51:42

Label at a glance#

ProductGORDONS UREA 40

Active ingredientUrea

Label structure7 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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 SECTION

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 SECTION

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 SECTION

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of Urea 40 Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
10481-3005-1	2021-11-04	C162847	48780-1	960f7f55-c90e-8e05-e053-dbdaa90a074a	GORDONS UREA 40
10481-3005-1	2019-10-29	C162847	48780-1	960f7f55-c90e-8e05-e053-dbdaa90a074a	GORDONS UREA 40

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
10481-3005-1	GM - Gram	10481-3005	b82df555-7523-4503-bfa5-3eb306df0352	1	2012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Urea	ACTIVE INGREDIENT	8W8T17847W	3
Urea	ACTIVE MOIETY	8W8T17847W	3
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	3
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	3
Water	INACTIVE INGREDIENT	059QF0KO0R	3
WHITE WAX	INACTIVE INGREDIENT	7G1J5DA97F	3

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

GORDONS UREA 40
UREA
Water
PETROLATUM
LANOLIN
WHITE WAX

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
10481-3005	10481-3005-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
Urea	8W8T17847W	ACTIB
Water	059QF0KO0R	IACT
PETROLATUM	4T6H12BN9U	IACT
LANOLIN	7EV65EAW6H	IACT
WHITE WAX	7G1J5DA97F	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 42 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LANOLIN	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / VAGINAL		40 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	AEROSOL, FOAM / TOPICAL	2 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / OPHTHALMIC	88.4 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM, AUGMENTED / TOPICAL	10 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	LOTION / TOPICAL	1.5 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, DELAYED RELEASE / ORAL	0.08 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE / ORAL		79 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE / VAGINAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / VAGINAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / RECTAL		105 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CAPSULE, EXTENDED RELEASE / ORAL		71 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, COATED / ORAL	3 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, FILM COATED / ORAL	0.2 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	SUPPOSITORY / RECTAL	265 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SUPPOSITORY / VAGINAL	27 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT / TOPICAL		2100 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	OINTMENT, AUGMENTED / TOPICAL		429 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	CREAM / TOPICAL		500 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET, EXTENDED RELEASE / ORAL	14 mg		Exact identifier — unii candidate 15 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	LOTION / TOPICAL	1 %w/w		Exact identifier — unii candidate 15 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
WHITE WAX	WHITE WAX	7G1J5DA97F	TABLET / ORAL	5 mg		Exact identifier — unii candidate 15 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
cff99f39-404d-2e18-e053-2995a90ac81b			f0b2b115-653c-4b3d-96ff-df94bd0d25bb	2021-11-04	Warnings	Exact identifier spl set id: f0b2b115-653c-4b3d-96ff-df94bd0d25bb

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.