EAR WAX TREATMENT- carbamide peroxide solution/ drops 
Rebel Distributors Corp

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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Rugby®
Earwax
Treatment
Drops

Drug Facts

Active ingredient

Carbamide peroxide 6.5%

Purpose

Earwax removal aid

Use

softens, loosens and removes excessive earwax

Warnings

Do not use for more than 4 days

Ask a doctor before use if you have

  • ear drainage or discharge
  • ear pain, irritation, rash or are dizzy
  • an injury or perforation (hole) of the eardrum or if you had ear surgery

When using this product avoid contact with the eyes

Stop use and ask a doctor if earwax remains longer than 4 days

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:

children under 12 years: ask a doctor

Other information

Inactive ingredients

citric acid (anhydrous), glycerin, propylene glycol, purified water, sodium acid pyrophosphate, sodium citrate (anhydrous), trolamine

Questions or comments?

Call 1-800-645-2158
9am - 5pm ET
Monday - Friday

Repackaged by:

Rebel Distributors Corp

Thousand Oaks, CA 91320

PRINCIPAL DISPLAY PANEL - 15 mL Carton

COMPARE TO
ACTIVE INGREDIENT IN
DEBROX®*

Rugby®
NDC 21695-334-15

Earwax
Treatment
Drops

Carbamide Peroxide 6.5 %

Helps Remove
Excessive Earwax

1/2 fl oz (15 mL)

SATISFACTION GUARANTEED
Rugby
OR YOUR MONEY BACK

Ear Treatment 6.5%

EAR WAX TREATMENT 
carbamide peroxide solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-334(NDC:0536-3000)
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carbamide Peroxide (UNII: 31PZ2VAU81) (Carbamide Peroxide - UNII:31PZ2VAU81) Carbamide Peroxide81.86 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water (UNII: 059QF0KO0R)  
Citric Acid Monohydrate (UNII: 2968PHW8QP)  
Glycerin (UNII: PDC6A3C0OX)  
Sodium Acid Pyrophosphate (UNII: H5WVD9LZUD)  
Sodium Citrate (UNII: 1Q73Q2JULR)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Trolamine (UNII: 9O3K93S3TK)  
Product Characteristics
ColorYELLOW (Colorless to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21695-334-1515 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34410/26/2009
Labeler - Rebel Distributors Corp (118802834)
Establishment
NameAddressID/FEIBusiness Operations
Rebel Distributors Corp118802834RELABEL, REPACK

Revised: 2/2011
Document Id: 22b7f3d7-7f3e-437f-9326-3eef737edfbb
Set id: 22b7f3d7-7f3e-437f-9326-3eef737edfbb
Version: 1
Effective Time: 20110209
 
Rebel Distributors Corp