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Best Choice Earwax Removal Kit

Medically reviewed on November 27, 2017.

Dosage form: liquid
Ingredients: CARBAMIDE PEROXIDE 65mg in 1mL
Labeler: Valu Merchandisers, Co.
NDC Code: 63941-835

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.

Best Choice Earwax Removal Kit

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

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

Best Choice Earwax Removal Kit  ´╗┐CARBAMIDE PEROXIDE 6.5%  Earwax Removal Aid  Safe, Gentle, Non-Irritating   washer bulb included  0.5 FL (15 mL)

BEST CHOICE EARWAX REMOVAL KIT 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-835
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (HYDROGEN PEROXIDE) CARBAMIDE PEROXIDE65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS CITRIC ACID 
GLYCERIN 
PROPYLENE GLYCOL 
SODIUM CITRATE 
SODIUM LAURYL SULFATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:63941-835-331 BOTTLE, DISPENSING in 1 CARTON
115 mL in 1 BOTTLE, DISPENSING
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34411/27/2014
Labeler - Valu Merchandisers, Co. (868703513)
Establishment
NameAddressID/FEIOperations
Bell Pharmaceuticals, Inc.140653770manufacture(63941-835)

 
Valu Merchandisers, Co.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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