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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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 finalpart34401/01/2020
Labeler - Retail Business Services, LLC (967989935)
Establishment
NameAddressID/FEIBusiness Operations
Bell Pharmaceuticals, Inc.140653770manufacture(72476-838) , label(72476-838)

Revised: 3/2020
Document Id: a0a6c2e9-d6f4-4527-e053-2995a90a51a1
Set id: 13a161c6-bc06-4315-9cc9-fe49d046cd6f
Version: 1
Effective Time: 20200312
 
Retail Business Services, LLC