GERI-CARE Dibucaine Ointment 1%

Manufacturer
Geri-Care Pharmaceuticals, Corp | Trifecta Pharmaceuticals USA LLC.
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:47:46

Label at a glance#

ProductDibucaine
Active ingredientDIBUCAINE
Label structure14 sections

Dosage and administration

Adults and children 12 years of age or older. 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

Storage and handling

Store at 20º-25ºC (68º-77ºF) T amper-evident; do not use if foil seal is broken or missing

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, pain, 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 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

STORAGE AND HANDLING SECTION

  • Store at 20º-25ºC (68º-77ºF)

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

Distributed By

SPL UNCLASSIFIED SECTION

Geri-Care Pharmaceuticals Corp.

1650 63rd Street

Brooklyn, NY 11204

1-800-540-3765

Product of China

* This product is not manufactured or distributed by the owner of the registered trademark Nupercainal®

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

gericare-dibucaine-1oz-CDERgericare-dibucaine-1oz-CDER

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238784dibucaine 1 % Rectal OintmentPSN4
238784dibucaine 0.01 MG/MG Rectal OintmentSCD4
238784dibucaine 1 % Rectal OintmentSY4

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
57896-131-01Dibucaine28 g in 1 TUBEOINTMENT284
57896-131-01Dibucaine1 in 1 BOXOINTMENT14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-131DIBUCAINE (DIBUCAINE 1%) OINTMENT [GERI-CARE PHARMACEUTICALS, CORP]4Current NDC, Legacy NDC, 2 package rows20241222_afe88610-5cac-960e-e053-2a95a90a7ba4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-131-01GM - Gram57896-1314a04f944-b7c2-4d7f-89f2-4e034d961b0812021-10-08

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
57896-13157896-131-01

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%Geri-Care Pharmaceuticals, Corpafe88610-5cac-960e-e053-2a95a90a7ba42024-12-20WarningsExact identifier
ndc (package): 57896-131-01
ndc (product): 57896-131
ndc11 (package): 57896013101
spl id: 29b472b9-6743-2403-e063-6294a90a22d0
spl set id: afe88610-5cac-960e-e053-2a95a90a7ba4

Reported adverse events (FAERS/openFDA)#

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