FDA.reportPublic FDA data

CVS Hemorrhoidal Cream Lidocaine 5% Rapid Pain Relief with 10 Finger Cots

Manufacturer
CVS PHARMACY, INC
Effective date
2026-01-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:32:10

Label at a glance#

ProductCVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots
Active ingredientLIDOCAINE
Label structure8 sections

Indications and uses

helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Dosage and administration

when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying. adults and children 12 years and older: apply externally to the affected area up to 6 times a day. children under 12 years of age: consult a doctor To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 5% w/w

Purpose

OTC - PURPOSE SECTION

Local anesthetic

Uses

INDICATIONS & USAGE SECTION

helps relieve the pain, itching and burning associated with hemorrhoids and other anorectal disorders.

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days
  • allergic reaction occurs to ingredients in this product
  • symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
  • symptoms clear up and return within a few days

If pregnant or breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health 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

  • when practical, clean area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • adults and children 12 years and older: apply externally to the affected area up to 6 times a day.
  • children under 12 years of age: consult a doctor
  • To use finger cots: Roll one finger cot over finger. Gently squeeze cream onto finger cot. Smooth a layer of the cream over affected area.

Other information

SPL UNCLASSIFIED SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera oil, benzyl alcohol, carbomer homopolymer, cholesterol, isopropyl myristate, mineral oil, polysorbate 80, propylene glycol, purified water, sodium hydroxide, vitamin E

Questions?

OTC - QUESTIONS SECTION

1-800-639-3803Weekdays 9 AM to 4 PM EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN1
1366789lidocaine 50 MG/ML Rectal CreamSCD1
1366789lidocaine 5 % Rectal CreamSY1

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428031230GTIN-13: 0050428031230
EAN-13: 0050428031230
GTIN-12: 050428031230
UPC-A: 050428031230
GTIN storage (14 digits): 00050428031230		Outer Package.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51316-204-01CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots1 in 1 KITKIT11
51316-206-01CVS Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger Cots30 g in 1 TUBECREAM30 g50 mg in 1g1

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51316-20451316-204-01
51316-20651316-206-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CHOLESTEROL97C5T2UQ7JIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
MINERAL OILT5L8T28FGPIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM HYDROXIDE55X04QC32IIACT
.ALPHA.-TOCOPHEROLH4N855PNZ1IACT
LIDOCAINE98PI200987ACTIB

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 Hemorrhoidal Lidocaine 5 Rapid Pain Relief with 10 Finger CotsLIDOCAINECVS PHARMACY, INCcaef51a8-76e9-42b3-a160-c54f62b47de12026-01-05WarningsExact identifier
ndc (package): 51316-206-01
ndc (package): 51316-204-01
ndc (product): 51316-204
ndc11 (package): 51316020401
ndc11 (package): 51316020601
spl id: 47a6704b-8de3-3fed-e063-6394a90afda6
spl set id: caef51a8-76e9-42b3-a160-c54f62b47de1

Reported adverse events (FAERS/openFDA)#

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