LEADER EARWAX REMOVAL DROPS EARWAX REMOVAL AID- carbamide peroxide solution/ drops 
Cardinal Health, Inc.

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Leader Earwax Removal Drops Earwax Removal Aid

Drug Facts

Active ingredient

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Uses

for occasional use as an aid to soften, loosen, and remove excessive earwax

Warnings

For use in the ear only

Ask a doctor before use if you have

  • ear drainage or discharge
  • ear pain
  • irritation, or rash in the ear 
  • dizziness
  • an injury or perforation (hole) of the ear drum
  • recently had ear surgery

When using this product

  • avoid contact with the eyes

Stop use and ask a doctor if

  • you need to use for more than 4 days
  • excessive earwax remains after use of this product

Keep out of reach of children.

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

Directions

FOR USE IN THE EAR ONLY
Adults and children over 12 years of age:

Other information

Inactive ingredients

anhydrous citric acid, glycerin, propylene glycol, sodium citrate, sodium lauryl sulfate, water

Questions?

1-800-328-5890
Weekdays 8:30-5:00 CST

Package Labeling:

Label2

LEADER EARWAX REMOVAL DROPS EARWAX REMOVAL AID 
carbamide peroxide solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0688
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:70000-0688-11 in 1 BOX07/09/2024
115 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01407/09/2024
Labeler - Cardinal Health, Inc. (063997360)

Revised: 7/2024
Document Id: 1d4f92ac-252f-f43f-e063-6394a90a6edd
Set id: 0022a174-8377-44af-84a9-31adb27de131
Version: 1
Effective Time: 20240715
 
Cardinal Health, Inc.