AUDIOLOGISTS CHOICE EARWAX REMOVAL AID DROPS- carbamide peroxide solution/ drops 
Oaktree Products Inc

----------

Audiologists Choice Earwax Removal Aid 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

Adult and children over 12 years of age:

Children under 12 years: consult a doctor

Other information

Inactive ingredients

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

Questions?

1-800-347-1960

Package Labeling:

Bottle

AUDIOLOGISTS CHOICE EARWAX REMOVAL AID DROPS 
carbamide peroxide solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59256-836
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
SODIUM CITRATE (UNII: 1Q73Q2JULR)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
WATER (UNII: 059QF0KO0R)  
ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:59256-836-341 in 1 CARTON06/01/2016
115 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01406/01/2016
Labeler - Oaktree Products Inc (800748329)
Establishment
NameAddressID/FEIBusiness Operations
Bell Pharmaceuticals, Inc.140653770manufacture(59256-836)

Revised: 12/2023
Document Id: 0c7fd25e-6acf-1a54-e063-6294a90af27d
Set id: 2922dde2-d082-437b-8f51-4a91ced20a58
Version: 2
Effective Time: 20231214
 
Oaktree Products Inc