Rugby® Earwax Treatment Drops

Drug Labeling and Warnings

Drug Details [pdf]

EAR WAX TREATMENT- carbamide peroxide solution/ drops 
Rugby Laboratories Inc.

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:

  • 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

PRINCIPAL DISPLAY PANEL - 15 mL Carton

COMPARE TO
ACTIVE INGREDIENT IN
DEBROX®*

Rugby®
NDC: 0536-3000-94

Earwax
Treatment
Drops

Carbamide Peroxide 6.5 %

Helps Remove
Excessive Earwax

1/2 fl oz (15 mL)

SATISFACTION GUARANTEED
Rugby
OR YOUR MONEY BACK

Principal Display Panel - 15 mL Carton
EAR WAX TREATMENT 
carbamide peroxide solution/ drops
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 0536-3000
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CARBAMIDE PEROXIDE (UNII: 31PZ2VAU81) (HYDROGEN PEROXIDE - UNII:BBX060AN9V) 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, UNSPECIFIED FORM (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: 0536-3000-9415 mL in 1 BOTTLE; Type 0: Not a Combination Product10/26/200905/31/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34410/26/200905/31/2018
Labeler - Rugby Laboratories Inc. (079246066)

Revised: 9/2019
Document Id: 5dc265ba-1712-442a-a9be-95fb71557359
Set id: b31d2529-c7a3-46fc-8e93-f69515a8934b
Version: 2
Effective Time: 20190906
 
Rugby Laboratories Inc.