FDA.reportPublic FDA data

Haemorrhoidal Pain Relief

Manufacturer
NeilMed Pharmaceuticals Inc
Effective date
2026-06-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-07-31 05:10:06

Label at a glance#

ProductHaemorrhoidal Pain Relief
Active ingredientLIDOCAINE
Label structure15 sections

Indications and uses

Temporarily relieves Pain and Itching due to anorectal disorders

Dosage and administration

Clean the area with mild soap and warm water and rinse thoroughly. Gently dry the area by patting or blotting with toilet tissue or a soft cloth before applying to the affected area up to six (6) times per day. Recommended for use by adults and children 12 years and older.

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients

Lidocaine 5%

Purpose

Local Anesthetic

Active IngredientActive Ingredient

Uses

OTC - PURPOSE SECTION

PurposePurpose

Temporarily relieves Pain and Itching due to anorectal disorders

Warnings

WARNINGS SECTION

When Using this Product

  • Avoid contact with eyes
  • do not exceed recommended dosage unless directed by a doctor WarningsWarnings

Stop Use and ask a doctor if you have

OTC - ASK DOCTOR SECTION

  • Rectal bleeding occurs
  • condition worserns or does not improve within 7 days
  • allergic reaction occurs
  • redness, irritaion, swelling, pain or other symptoms begin or increase
  • symptoms clearup and return within a few days

Ask a doctor ifAsk a doctor if

Stop Use and Ask a doctor if

OTC - STOP USE SECTION

Rectal bleeding occurs
condition worserns or does not improve within 7 days
allergic reaction occurs
redness, irritaion, swelling, pain or other symptoms begin or increase
symptoms clearup and return within a few days

Stop use and ask a doctorStop use and ask a doctor

Uses

OTC - WHEN USING SECTION

When using this product
■ avoid contact with eyes
■ do not exceed recommended dosage unless directed to do so by a doctor When Using this ProductWhen Using this Product

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

Keep out of reach of childrenKeep out of reach of children

Directions

INSTRUCTIONS FOR USE SECTION

Clean the area with mild soap and warm water and rinse thoroughly.
Gently dry the area by patting or blotting with toilet tissue or a soft cloth before applying to the affected area up to six (6) times per day.
Recommended for use by adults and children 12 years and older. Instructions For UseInstructions For Use

Other Information

OTHER SAFETY INFORMATION

Do not exceed 30°C (86°F). Protect from freezing. Other Safety InformationOther Safety Information

Inacive Ingredients

INACTIVE INGREDIENT SECTION

benzyl alcohol, carbomer 940, cholesterol, hydrogenated lecithin, isopropyl myristate, polysorbate 80, propylene glycol, tocopheryl acetate, trolamine, purified water. Inactive IngredientsInactive Ingredients

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to anorectal disorders. UsesUses

Directions

DOSAGE & ADMINISTRATION SECTION

Clean the area with mild soap and warm water and rinse thoroughly.

Gently dry the area by patting or blotting with toilet tissue or a soft cloth before applying to the affected area up to six (6) times per day.

Recommended for use by adults and children 12 years and older. DirectionsDirections

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

Ask a health professional before use If pregnant or breast-feedingIf pregnant or breast-feeding

Stop use and ask a doctor If

OTC - DO NOT USE SECTION

Bleeding occurs
■ Condition worsens or does not improve within 7 days
■ An allergic reaction occurs
■ The symptom being treated does not subside or if redness, irritation, swelling,
pain or other symptoms develop or increase

Stop UseStop Use

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Haemorrhoidal Pain Relief Anorectal Cream

5% Lidocaine

Highest OTC strength licodaine available

Rapid, numbing relief from pain,burning, itching, &discomfort

Net WT 1 OZ (28g) Packaging label principal display panelsPackaging label principal display panels

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
QR code linkQR Codedigestives.neilmed.com/products/hemorrhoidal-cream-with-lidocainePK-IC163-Rev1-Hemorrhoidal PainRelief-Cream 1 oz (1)_page-0001.jpg

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
13709-35813709-358-01

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
LIDOCAINE98PI200987ACTIB
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER 9404Q93RCW27EIACT
CHOLESTEROL97C5T2UQ7JIACT
HYDROGENATED SOYBEAN LECITHINH1109Z9J4NIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
TROLAMINE9O3K93S3TKIACT
WATER059QF0KO0RIACT

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
Haemorrhoidal Pain ReliefANORECTAL CREAMNeilMed Pharmaceuticals Inc544a9d6f-4eaa-613e-e063-6294a90a0c502026-06-15WarningsExact identifier
ndc (package): 13709-358-01
ndc (product): 13709-358
ndc11 (package): 13709035801
spl id: 544a9d6f-4eab-613e-e063-6294a90a0c50
spl set id: 544a9d6f-4eaa-613e-e063-6294a90a0c50

Reported adverse events (FAERS/openFDA)#

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