FDA.reportPublic FDA data

Hemorrhoid Relief Cream

Manufacturer
Wal-Mart Stores Inc | LNK International, Inc.
Effective date
2024-04-20
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
legacy-cache
Hydrated at
2026-08-01 21:04:47

Label at a glance#

ProductHemorrhoid Relief Cream
Active ingredientLIDOCAINE
Label structure9 sections

Indications and uses

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

Dosage and administration

when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product. adults and children 12 years and over: apply externally to the affected area up to 6 times daily children under 12 years: consult a doctor

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) see end flap for expiration date and lot number

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

If pregnant or breast-feeding,

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.
  • adults and children 12 years and over: apply externally to the affected area up to 6 times daily
  • children under 12 years: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, benzyl alcohol, carbomer, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, purified water, triethanolamine, vitamin E acetate, vitis vinifera (grape) skin extract

Questions or comments?

OTC - QUESTIONS SECTION

1-888-287-1915

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 49035-717-43

equate™

Compare to
RectiCare®
Active
Ingredient*

Hemorrhoid
Relief Cream

Lidocaine 5%
Anorectal Cream

• Helps relieve pain and burning

• For the temporary relief of itching and
discomfort associated with hemorrhoids
and other anorectal disorders

• Highest lidocaine strength
available over-the-counter

NET WT 1 OZ (30 g)

TAMPER EVIDENT: DO NOT
USE IF FOIL SEAL UNDER
CAP IS BROKEN OR
MISSING OR TUBE IS
DAMAGED

Satisfaction guaranteed
– Or we’ll replace it or
give you your money
back. For questions or
comments or to report
an undesired reaction
or side effect, please
call 1-888-287-1915.

DISTRIBUTED BY:
Walmart Inc.,
Bentonville, AR 72716

*This product is not
manufactured or distributed
by Ferndale IP, Inc., owner of
the registered trademark
RectiCare®.

50844 ORG121871743

Equate 44-717
Equate 44-717

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
49035-717HEMORRHOID RELIEF CREAM (LIDOCAINE) CREAM [WAL-MART STORES INC]8Legacy NDC20240421_68fa8293-5ce3-4712-ad1e-46f73c5c01fd.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
49035-71749035-717-43

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
LIDOCAINE98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE0A5MM307FCIACT
CHOLESTEROL97C5T2UQ7JIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
VITIS VINIFERA ANTHOCYANINSF02KPB2508IACT

Source Document#

Source XML · Source PDF

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
c328691f-f37e-4632-96bd-cf6f686c89b368fa8293-5ce3-4712-ad1e-46f73c5c01fd2025-04-26WarningsExact identifier
spl set id: 68fa8293-5ce3-4712-ad1e-46f73c5c01fd

Reported adverse events (FAERS/openFDA)#

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