Audiologist’s Choice EARWAX REMOVAL SYSTEM Earwax Removal

Audiologist’s Choice EARWAX REMOVAL SYSTEM Earwax Removal

Drug Labeling and Warnings

Drug Details

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AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM EARWAX REMOVAL - carbamide peroxide liquid 
Oaktree Products Inc.

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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Audiologist’s Choice EARWAX REMOVAL SYSTEM Earwax Removal

Drug facts


Active ingredient

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Uses

for occasional use as an aid to soften, looser, 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 titled 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

*This product is not manufactured or distributed by Prestige Brands Inc. owner of the registered trademark Debrox.

Distributed By:  Oaktree Production Inc.  St. Louis, Mo.63005  Made In USA

Audiologist's Choice  Earwax Removal Aid  Carbamide Peroxide 6.5%  Safe, Gentle, Non-Irritating  Compare to Debrox active ingredient  Washer Bulb Included  0.5 FL OZ (15mL)

Product Labels

Audiologist’s Choice 01

AUDIOLOGISTS CHOICE EARWAX REMOVAL SYSTEM EARWAX REMOVAL  
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 59256-001
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: 59256-001-021 in 1 CARTON
115 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34411/28/2014
Labeler - Oaktree Products Inc. (800748329)
Establishment
NameAddressID/FEIBusiness Operations
Bell Pharmaceuticals, Inc.140653770manufacture(59256-001)

Revised: 12/2014
 
Oaktree Products Inc.


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