FDA.reportPublic FDA data

DIBUCAINE 1% Ointment

Manufacturer
NUGERI LLC | UNIPack
Effective date
2022-01-01
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:04:13

Label at a glance#

ProductDIBUCAINE
Active ingredientDIBUCAINE
Label structure1 sections

Label contents#

Full prescribing information#

Product Image

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dibucaine TubeDibucaine Tube

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dibucaine 1%

Purpose

OTC - PURPOSE SECTION

Hemmorrhoidal ointment

Use

INDICATIONS & USAGE SECTION

Temporarily relieves pain and itching due to hemorrhoids or other anorectal disorders

Warnings

WARNINGS SECTION

For external use only

Allery Alert

PRECAUTIONS SECTION

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

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

OTC - ASK DOCTOR SECTION

  • Bleeding occurs
  • Conditions worsens or does not improve within 7 days

If Pregnant Or Breat-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.

Directons

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years and older; if possible clean the affected area with mild soap and warm water and rinse thoroughly. Dry by patting or blotting with toliet tissue or 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

STORAGE AND HANDLING SECTION

  • Store at 20-25 0 C (68-77 0 F)
  • Tamper-evident: do not use if foil seal is broken or missing

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Dibuacine 1% Local Anesthetic

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hemorrhoidal Ointment

For Fast, temporary relief of hemorrhodial pain, itching, and burning

Compare to the active ingredients in Nupercainal ointment

Contains

HOW SUPPLIED SECTION

NET WT. 1 Oz. (28g)

Manufactured And Distributed By

REFERENCES SECTION

Manufactured By:

Unipack, Inc.

Pittsburgh, PA 15239

info@unipackinc.com

1-724-733-7381

Distributed By

Nugeri, LLC

Tarrytown, NY 10591

info@nurgerirx.com

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
81266-920-01GM - Gram81266-920bc5f4440-58ae-49f5-b9ad-f3e83dbe817112022-05-04

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
81266-92081266-920-01

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
NameUNIIKind
DIBUCAINEL6JW2TJG99ACTIB
LANOLIN7EV65EAW6HIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
WATER059QF0KO0RIACT
LIGHT MINERAL OILN6K5787QVPIACT

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
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
0874bae1-eb7b-3c08-e063-6294a90aaba0b6ca4519-6c8e-49e0-e053-2995a90af8002023-10-24WarningsExact identifier
spl set id: b6ca4519-6c8e-49e0-e053-2995a90af800

Reported adverse events (FAERS/openFDA)#

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