CAREONE EARWAX REMOVAL DROPS- carbamide peroxide solution/ drops 
Retail Business Services, LLC

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CareOne Earwax Removal Drops

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 right away.

Directions

FOR USE IN THE EAR ONLY

Adults and children over 12 years of age:

Children under 12 years: consult a doctor

Other information

Inactive ingredients

Questions?

1-800-328-5890

Package Labeling:

Label

CAREONE EARWAX REMOVAL DROPS 
carbamide peroxide solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-838
Route of AdministrationAURICULAR (OTIC)
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:72476-838-341 in 1 BOX01/01/2020
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 DrugM01401/01/2020
Labeler - Retail Business Services, LLC (967989935)
Establishment
NameAddressID/FEIBusiness Operations
Bell Pharmaceuticals, Inc.140653770manufacture(72476-838)

Revised: 12/2023
Document Id: 0c801757-f335-cd4d-e063-6294a90a433b
Set id: 13a161c6-bc06-4315-9cc9-fe49d046cd6f
Version: 2
Effective Time: 20231214
 
Retail Business Services, LLC