Globe Dibucaine Ointment 1%

Manufacturer
Trifecta Pharmaceuticals USA LLC | Trifecta Pharmaceuticals USA LLC.
Effective date
2024-01-02
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:28

Label at a glance#

ProductDibucaine
Active ingredientDIBUCAINE
Label structure15 sections

Dosage and administration

Adults and children 12 years of age or older. If possible, clean the affected area by platting or blotting with an appropriate cleansing wipe, gently dry by patting or blotting with a 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

Storage and handling

Store at room temperature 20º-25ºC (68º-77ºF)

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Dibucaine 1%

OTC - PURPOSE SECTION

Hemorrhoidal Ointment

INDICATIONS & USAGE SECTION

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

If Pregnant or Breast-Feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health care professional before use.

Stop Use and ask a doctor

OTC - STOP USE SECTION

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

Keep out of the reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Do Not Use

OTC - DO NOT USE SECTION

In or near eyes

In children under 2 years of age

Warnings

WARNINGS SECTION

For External use only

Allergy alert

Certain persons can develop allergic reactions to ingredients in this product.

If the symptoms being treated do not subside or if redness, irritation, swelling, bleeding or other symptoms develop 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adults and children 12 years of age or older. If possible, clean the affected area by platting or blotting with an appropriate cleansing wipe, gently dry by patting or blotting with a 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

Questions or Comments?

OTC - QUESTIONS SECTION

Call Toll Free 1-888-296-9067

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature 20º-25ºC (68º-77ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Lanolin, Light Mineral Oil, Purified Water, White Petrolatum

Distributed By

SPL UNCLASSIFIED SECTION

Trifecta Pharmaceuticals USA

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301 USA

1-888-296-9067

Made in China

* This product is not manufactured or distributed by Ducere Pharma, Distributor of Nuper-Cainal

Child Resistant Packaging

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

globe-dibucaine-1oz-CDERglobe-dibucaine-1oz-CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238784dibucaine 1 % Rectal OintmentPSN2
238784dibucaine 0.01 MG/MG Rectal OintmentSCD2
238784dibucaine 1 % Rectal OintmentSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DIBUCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-023-01Dibucaine28.4 g in 1 TUBEOINTMENT28.42
69396-023-01Dibucaine1 in 1 BOXOINTMENT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-023DIBUCAINE (DIBUCAINE 1%) OINTMENT [TRIFECTA PHARMACEUTICALS USA LLC]2Current NDC, Legacy NDC, 2 package rows20240103_e8a56651-a292-7609-e053-2a95a90a7c36.zip

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69396-02369396-023-01

Ingredients#

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

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

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
DibucaineDIBUCAINE 1%Trifecta Pharmaceuticals USA LLCe8a56651-a292-7609-e053-2a95a90a7c362024-01-02WarningsExact identifier
ndc (package): 69396-023-01
ndc (product): 69396-023
ndc11 (package): 69396002301
spl id: 0df7b6dd-a4d8-c9a6-e063-6394a90a0f52
spl set id: e8a56651-a292-7609-e053-2a95a90a7c36

Reported adverse events (FAERS/openFDA)#

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