FDA.reportPublic FDA data

CVS Topical Anesthetic Hemorrhoidal Ointment

Manufacturer
CVS PHARMACY, INC | Fourstar Group USA, Inc.
Effective date
2026-07-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-04 03:34:00

Label at a glance#

ProductCVS Topical Anesthetic Hemorrhoidal
Active ingredientDIBUCAINE
Label structure7 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 or 4 times daily. children under 12 years of age: ask a doctor.

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 or other anorectal disorders

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.

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 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 or 4 times daily.
  • children under 12 years of age: ask a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • store at room temperature 68° - 77° F (20° - 25° C).
  • 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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

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
51316-25051316-250-00

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
LIGHT MINERAL OILN6K5787QVPIACT
WATER059QF0KO0RIACT
WHITE PETROLATUMB6E5W8RQJ4IACT

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
CVS Topical Anesthetic HemorrhoidalDIBUCAINECVS PHARMACY, INC9f3d4fdb-ad82-4ab8-8a9e-252d027068ab2026-07-25WarningsExact identifier
ndc (package): 51316-250-00
ndc (product): 51316-250
ndc11 (package): 51316025000
spl id: 5770139a-a6f2-c38c-e063-6394a90a852a
spl set id: 9f3d4fdb-ad82-4ab8-8a9e-252d027068ab

Reported adverse events (FAERS/openFDA)#

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