Quality Choice Dibucaine Ointment 1%

Manufacturer
Chain Drug Marketing Association Inc. | Trifecta Pharmaceuticals USA LLC.
Effective date
2023-05-23
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:55:04

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 patting or blotting with appropriate cleansing wipes or with mild soap and warm water and rinse thoroughly. 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 patting or blotting with appropriate cleansing wipes or with mild soap and warm water and rinse thoroughly. 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 1-800-935-2362

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

Distributed by: CDMA, Inc.

Novi, MI 48375 USA

1-800-935-2362

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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

qc-dibucaine-1oz-CDER 2qc-dibucaine-1oz-CDER 2

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-911-012025-01-30C16284748780-12cef2736-99cd-d83d-e063-dadaa90ab31fQuality Choice Dibucaine Ointment 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-911-01Dibucaine1 in 1 BOXOINTMENT12
63868-911-01Dibucaine28.3 g in 1 TUBEOINTMENT28.32

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-911DIBUCAINE (DIBUCAINE 1%) OINTMENT [CHAIN DRUG MARKETING ASSOCIATION INC.]2Legacy NDC, 2 package rows20230525_eb3fe8ef-5d98-7787-e053-2a95a90ad8b2.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-911-01GM - Gram63868-911454b140f-a537-487e-b5ef-e5dd3a3049ed12022-12-07

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
63868-91163868-911-01

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
fc61847b-cb64-97b1-e053-6394a90ae1b9eb3fe8ef-5d98-7787-e053-2a95a90ad8b22023-05-23WarningsExact identifier
spl id: fc61847b-cb64-97b1-e053-6394a90ae1b9
spl set id: eb3fe8ef-5d98-7787-e053-2a95a90ad8b2

Reported adverse events (FAERS/openFDA)#

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