REXALL EARWAX REMOVAL- carbamide peroxide 
Dolgencorp 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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Rexall 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 eay 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:

Other information

Inactive ingredients

Questions?

1-866-4-REXALL

Package Labeling:

Kit 2Label3

REXALL EARWAX REMOVAL 
carbamide peroxide kit
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55910-835
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55910-835-331 in 1 BOX01/01/2019
11 in 1 KIT
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 BOTTLE 15 mL
Part 1 of 1
REXALL EARWAX REMOVAL DROPS 
carbamide peroxide solution/ drops
Product Information
Item Code (Source)NDC:55910-836
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
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:55910-836-3315 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34401/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34401/01/2019
Labeler - Dolgencorp LLC (068331990)

Revised: 10/2021
Document Id: cecbac50-e387-b453-e053-2995a90abb28
Set id: 9536e069-5bd5-4827-a5e9-f46e1d9d1219
Version: 4
Effective Time: 20211020
 
Dolgencorp LLC