REXALL EARWAX REMOVAL- carbamide peroxide 
Dolgencorp LLC

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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 DrugM01401/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01401/01/2019
Labeler - Dolgencorp LLC (068331990)

Revised: 12/2023
Document Id: 0c8655bc-43e3-2b67-e063-6394a90aafa3
Set id: 9536e069-5bd5-4827-a5e9-f46e1d9d1219
Version: 5
Effective Time: 20231215
 
Dolgencorp LLC