BEST CHOICE EARWAX REMOVAL KIT- carbamide peroxide liquid 
Valu Merchandisers, Co.

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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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:

Children under 12 years: consult a doctor

Other information

Inactive ingredients

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

BEST CHOICE EARWAX REMOVAL KIT 
carbamide peroxide liquid
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63941-835
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:63941-835-331 in 1 CARTON11/27/2014
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 finalpart34411/27/2014
Labeler - Valu Merchandisers, Co. (868703513)
Establishment
NameAddressID/FEIBusiness Operations
Bell Pharmaceuticals, Inc.140653770manufacture(63941-835)

Revised: 12/2019
Document Id: 99d34698-f3be-13b2-e053-2a95a90ac8f5
Set id: f943ac0e-8171-446d-8c6c-69612b482643
Version: 2
Effective Time: 20191216
 
Valu Merchandisers, Co.