CAREONE EARWAX REMOVAL KIT, EARWAX AND BULB- carbamide peroxide 
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 Kit, Earwax & Bulb

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:

  • Tilt head sideways and place 5 to 10 drops into ear
  • Tip of applicator should not enter ear canal
  • Keep drops in ear for several minutes by keeping head tilted or placing cotton in the ear
  • Use twice daily for up to 4 days if needed, or as directed by a doctor
  • Any wax remaining after treatment may be removed by gently flushing the ear with warm water, using a soft rubber bulb ear syringe

Children under 12 years: consult a doctor

Other information

  • Avoid exposing bottle to excessive heat and direct sunlight
  • Store bottle in the outer carton
  • Keep cap on bottle when not in use
  • Product foams on contact with earwax due to release of oxygen. There may be an associated crackling sound.
  • Do not use if tamper-evident safety seal is broken or missing

Inactive ingredients

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

Questions?

1-800-328-5890

Package Labeling:

Label2

CAREONE EARWAX REMOVAL KIT, EARWAX AND BULB 
carbamide peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72476-836
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72476-836-331 in 1 KIT01/01/202011/30/2021
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 15 mL
Part 1 of 1
CAREONE EARWAX REMOVAL DROPS 
carbamide peroxide solution/ drops
Product Information
Item Code (Source)NDC:72476-835
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:72476-835-331 in 1 BOX
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 finalpart34401/01/202011/30/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34401/01/202011/30/2021
Labeler - Retail Business Services, LLC (967989935)
Establishment
NameAddressID/FEIBusiness Operations
Bell Pharmaceuticals, Inc.140653770manufacture(72476-836) , label(72476-835)

Revised: 12/2021
Document Id: d31e9f48-eb3f-729a-e053-2a95a90a2494
Set id: 79349c1b-c96f-436d-9ba9-c4ecd07c36c4
Version: 3
Effective Time: 20211214
 
Retail Business Services, LLC