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Ear Wax Treatment by Rebel Distributors Corp

Medically reviewed on February 9, 2018.

Dosage form: solution/ drops
Ingredients: Carbamide Peroxide 81.86mg in 1mL
Labeler: Rebel Distributors Corp
NDC Code: 21695-334

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.

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:

  • 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 tilting head or placing cotton in ear
  • use twice daily for up to 4 days
  • remove any wax remaining after treatment by gently flushing ear with warm water using a soft rubber bulb ear syringe

children under 12 years: ask a doctor

Other information
  • store at room temperature 15° - 30°C (59° - 89°F)
  • keep in a dry place

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 WAX TREATMENT 
carbamide peroxide solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-334(NDC:0536-3000)
Route of AdministrationAURICULAR (OTIC)DEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carbamide Peroxide (Carbamide Peroxide) Carbamide Peroxide81.86 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Water 
Citric Acid Monohydrate 
Glycerin 
Sodium Acid Pyrophosphate 
Sodium Citrate 
Propylene Glycol 
Trolamine 
Product Characteristics
ColorYELLOW (Colorless to pale yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
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/FEIOperations
Rebel Distributors Corp118802834RELABEL, REPACK

 
Rebel Distributors Corp

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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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