FDA.reportPublic FDA data

Leader Maximum Strength Hemorrhoidal Relief Cream

Manufacturer
Cardinal Health,Inc.
Effective date
2025-03-21
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:57:37

Label at a glance#

ProductLeader Maximum Strength Hemorrhoidal Relief
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 (1-800-222-1222) 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, purifed water, sodium hydroxide, vitamin E

Questions?

OTC - QUESTIONS SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabelLabel0Label0

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1366789lidocaine 5 % Rectal CreamPSN2
1366789lidocaine 50 MG/ML Rectal CreamSCD2
1366789lidocaine 5 % Rectal CreamSY2

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0650-1Leader Maximum Strength Hemorrhoidal Relief1 in 1 CARTONCREAM12
70000-0650-1Leader Maximum Strength Hemorrhoidal Relief30 g in 1 TUBECREAM302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0650LEADER MAXIMUM STRENGTH HEMORRHOIDAL RELIEF (LIDOCAINE) CREAM [CARDINAL HEALTH,INC.]2Current NDC, 2 package rows20250323_65c780b0-7f47-4ae9-a847-c22deaaa2888.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0650-1GM - Gram70000-0650a59de945-402d-4dfc-be6a-ab15affbbb5912025-05-14

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-065070000-0650-1

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 TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED)4Q93RCW27EIACT
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
Leader Maximum Strength Hemorrhoidal ReliefLIDOCAINECardinal Health,Inc.65c780b0-7f47-4ae9-a847-c22deaaa28882025-03-21WarningsExact identifier
ndc (package): 70000-0650-1
ndc (product): 70000-0650
ndc11 (package): 70000065001
spl id: 30dcc962-8024-3383-e063-6294a90afac6
spl set id: 65c780b0-7f47-4ae9-a847-c22deaaa2888

Reported adverse events (FAERS/openFDA)#

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