Dibucaine Topical Anesthetic 1% Hemorrhoidal Ointment

Manufacturer: Rugby Laboratories Inc.
Effective date: 2025-05-29
Label type: HUMAN OTC DRUG LABEL
Version: 6
Source: full-release
Hydrated at: 2026-06-01 01:01:52

Label at a glance#

ProductDibucaine Topical Anesthetic 1% Hemorrhoidal

Active ingredientDIBUCAINE

Label structure8 sections

Dosage and administration

adults and children 12 years and over: If possible, clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or blotting with toilet tissue or a soft cloth before applying. apply externally to the affected area up to 3 to 4 times daily. children under 12 years of age: ask a doctor

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-800-639-3803

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Dibucaine 1%

Purpose

OTC - PURPOSE SECTION

Local Anesthetic

Use

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to hemorrhoids and other anorectal disorders

Warnings

WARNINGS SECTION

For external use only.

Allergy Alert

SPL UNCLASSIFIED SECTION

Certain persons can develop allergic reactions to ingredients in this product. If the symptoms being treated does not subside or if redness, irritaion, swelling, bleeding or other symptoms develop or increase, discontinue use and ask a doctor.

Do not use

OTC - DO NOT USE SECTION

in or near the eyes
in children under 2 years of age

When using this product

OTC - WHEN USING SECTION

do not use more than directed unless directed by a doctor.
do not put this product into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

bleeding occurs
condition worsens or does not improve within 7 days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over: If possible, clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or blotting with toilet tissue or a soft cloth before applying.
apply externally to the affected area up to 3 to 4 times daily.
children under 12 years of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

Store at 20 ^o-25 ^o C (68 ^o-77 ^o F)
tamper-evident: do not use if foil seal is broken or missing

undefined

INACTIVE INGREDIENT SECTION

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Questions or comments?

OTC - QUESTIONS SECTION

call 1-800-639-3803

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
198601	dibucaine 1 % Topical Ointment	PSN	6
198601	dibucaine 0.01 MG/MG Topical Ointment	SCD	6
198601	dibucaine 1 % Topical Ointment	SY	6
198601	dibucaine 1 GM per 100 GM Topical Ointment.	SY	6

DailyMed Pharmacologic Classes#

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
0536-1211-95	Dibucaine Topical Anesthetic 1% Hemorrhoidal	1 in 1 BOX	OINTMENT	1		6
0536-1211-95	Dibucaine Topical Anesthetic 1% Hemorrhoidal	28 g in 1 TUBE	OINTMENT	28		6

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
0536-1211-95	GM - Gram	0536-1211	1e8a974b-83de-487c-88fb-b112a93d9696	1	2019-09-05

Products#

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

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

Dibucaine Topical Anesthetic 1% Hemorrhoidal
DIBUCAINE
LANOLIN
LIGHT MINERAL OIL
WATER
PETROLATUM

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
0536-1211	0536-1211-95

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
LANOLIN	7EV65EAW6H	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
WATER	059QF0KO0R	IACT
PETROLATUM	4T6H12BN9U	IACT
DIBUCAINE	L6JW2TJG99	ACTIB

Source Document#

Source XML

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
Dibucaine Topical Anesthetic 1% Hemorrhoidal	DIBUCAINE	Rugby Laboratories Inc.	f23c8cd1-98f9-41cd-84d4-cf01c2ede29a	2025-05-29	Warnings	Exact identifier ndc (package): 0536-1211-95 ndc (product): 0536-1211 ndc11 (package): 00536121195 spl id: 364c388d-adc9-9763-e063-6294a90a77cd spl set id: f23c8cd1-98f9-41cd-84d4-cf01c2ede29a

Reported adverse events (FAERS/openFDA)#

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