DIBUCAINE OINTMENT USP, 1%

Manufacturer: E. Fougera & Co. a division of Fougera Pharmaceuticals Inc.
Effective date: 2012-07-25
Label type: HUMAN OTC DRUG LABEL
Version: 1
Source: full-release
Hydrated at: 2026-05-31 22:32:37

Label at a glance#

ProductDIBUCAINE

Active ingredientDIBUCAINE

Label structure11 sections

Contacts and useful links#

PhoneLabel contact1-800-645-9833

Label contents#

Full prescribing information#

Active Ingredient:

OTC - ACTIVE INGREDIENT SECTION

Dibucaine 1%

Purpose:

OTC - PURPOSE SECTION

Topical Anesthetic

INDICATIONS & USAGE SECTION

Uses:

for temporary relief of pain and itching associated with:
sunburn
minor burns
hemorrhoids
cuts
scratches
insect bites
stings

WARNINGS SECTION

Warnings:

For external use only

Do not use in the eyes

Stop use and ask a doctor if

the condition persists or if rash or irritation develops
you have rectal bleeding

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions:

not for prolonged use
adults should not use more than the tube in 24 hours or 1/4 tube for child
apply to affected area 3 or 4 times daily
cover with light dressing, if necessary

SPL UNCLASSIFIED SECTION

Other information:

store at room temperature.
see crimp of tube for Lot Number and Expiration Date.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

acetone sodium bisulfite 1/2% as a preservative, lanolin, purified water, white petrolatum

SPL UNCLASSIFIED SECTION

Questions or comments? call toll free 1-800-645-9833

E. FOUGERA & CO.

A division of Fougera Pharmaceuticals Inc.

Melville, NY 11747

C4905B

R12/11

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CONTAINER

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fougera^®

NDC 0168-0046-31

CHILD-RESISTANT PACKAGE

DIBUCAINE OINTMENT USP, 1%

TOPICAL ANESTHETIC

NET WT 28.35g (1 Oz)

FOR EXTERNAL USE ONLY

DO NOT USE IN THE EYES

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0168-0046-31

Fougera^®

DIBUCAINE OINTMENT USP, 1%

TOPICAL ANESTHETIC

NET WT 28.35g (1 Oz)

Laminate Tube with Child-Resistant Cap

FOR EXTERNAL USE ONLY

DO NOT USE IN THE EYES

PACKAGE LABEL – PRINCIPAL DISPLAY PANEL – CARTON

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198601	dibucaine 1 % Topical Ointment	PSN	1
198601	dibucaine 0.01 MG/MG Topical Ointment	SCD	1
198601	dibucaine 1 % Topical Ointment	SY	1
198601	dibucaine 1 GM per 100 GM Topical Ointment.	SY	1

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
DIBUCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
0168-0046-31	2020-01-31	C162847	48780-1	9d75b9d1-1b2d-f424-e053-dadaa90a57ce	DIBUCAINE OINTMENT USP, 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0168-0046-31	DIBUCAINE	28 g in 1 TUBE	OINTMENT	28		1
0168-0046-31	DIBUCAINE	1 in 1 CARTON	OINTMENT	1		1

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
0168-0046	DIBUCAINE OINTMENT [E. FOUGERA & CO. A DIVISION OF FOUGERA PHARMACEUTICALS INC.]	1	Legacy NDC, 2 package rows	20120725_8ae5992a-c544-4fd8-93f8-0f97c653203c.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0168-0046-31	GM - Gram	0168-0046	475f6fa8-936e-43dc-8b06-fd5bf27af28f	1	2013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
DIBUCAINE	ACTIVE INGREDIENT	L6JW2TJG99	1
DIBUCAINE	ACTIVE MOIETY	L6JW2TJG99	1
ACETONE SODIUM BISULFITE	INACTIVE INGREDIENT	47VY054OXY	1
LANOLIN	INACTIVE INGREDIENT	7EV65EAW6H	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

DIBUCAINE
ACETONE SODIUM BISULFITE
LANOLIN
PETROLATUM
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0168-0046	0168-0046-31

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
DIBUCAINE	L6JW2TJG99	ACTIB
ACETONE SODIUM BISULFITE	47VY054OXY	IACT
LANOLIN	7EV65EAW6H	IACT
PETROLATUM	4T6H12BN9U	IACT
WATER	059QF0KO0R	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 · 27 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
LANOLIN	LANOLIN	7EV65EAW6H	SHAMPOO / TOPICAL	2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LIQUID / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	EMULSION / TOPICAL	0.25 %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
PETROLATUM	PETROLATUM	4T6H12BN9U	SPONGE / TOPICAL	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / OPHTHALMIC	3 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET / ORAL	3.5 mg		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
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / AURICULAR (OTIC)	NA		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	EMULSION / TOPICAL	7.8 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	SOAP / TOPICAL	0.85 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		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
LANOLIN	LANOLIN	7EV65EAW6H	CREAM / TOPICAL		10 mg	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
LANOLIN	LANOLIN	7EV65EAW6H	OINTMENT / TOPICAL	10 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 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	AEROSOL, FOAM / TOPICAL	7.9 %w/w		Exact identifier — unii candidate 18 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	OINTMENT / OPHTHALMIC	88.4 %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
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL		4213 mg	Exact identifier — unii candidate 18 equally ranked IID candidates
LANOLIN	LANOLIN	7EV65EAW6H	SPRAY / NASAL	NA		Exact identifier — unii candidate 9 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / TOPICAL		7275 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
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT / VAGINAL		4084 mg	Exact identifier — unii candidate 18 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
cc66c053-6c73-4d9b-979b-f508f7c0aa5c			8ae5992a-c544-4fd8-93f8-0f97c653203c	2012-07-25	Warnings	Exact identifier spl id: cc66c053-6c73-4d9b-979b-f508f7c0aa5c spl set id: 8ae5992a-c544-4fd8-93f8-0f97c653203c

Reported adverse events (FAERS/openFDA)#

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