LEADER MAXIMUM STRENGTH HEMORRHOIDAL RELIEF- lidocaine cream 
Cardinal Health,Inc.

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Leader Maximum Strength Hemorrhoidal Relief Cream

Drug Facts

Active ingredient

Lidocaine 5% w/w

Purpose

Local anesthetic

Uses

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

Warnings

For external use only.

When using this product

  • 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

  • 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

ask a health professional before use.

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

Other information

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

Inactive ingredients

aloe oil, benzyl alcohol, carbomer 940, cholesterol, isopropyl myristate, mineral oil, polysorbate 80, propylene glycol, purified water, trolamine, vitamin E

Questions?

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

Package Labeling:

Outer PackageInner Package

LEADER MAXIMUM STRENGTH HEMORRHOIDAL RELIEF 
lidocaine cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0650
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE50 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)  
CARBOMER HOMOPOLYMER TYPE C (ALLYL PENTAERYTHRITOL CROSSLINKED) (UNII: 4Q93RCW27E)  
CHOLESTEROL (UNII: 97C5T2UQ7J)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
WATER (UNII: 059QF0KO0R)  
TROLAMINE (UNII: 9O3K93S3TK)  
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0650-11 in 1 CARTON02/01/2024
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01502/01/2024
Labeler - Cardinal Health,Inc. (063997360)

Revised: 12/2023
Document Id: 0c7dc0e1-7c3f-ab15-e063-6294a90a15b5
Set id: 65c780b0-7f47-4ae9-a847-c22deaaa2888
Version: 1
Effective Time: 20231214
 
Cardinal Health,Inc.