EARWAX TREATMENT DROPS- carbamide peroxide solution 
Preferred Pharmaceuticals 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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Earwax Treatment Drops

Drug Facts

Active Ingredient

Carbamide peroxide 6.5%

Purpose

Ear wax removal aid

Uses

for occasional use as an aid to

•
soften
•
loosen
•
remove excessive ear wax

Warnings

For use in the ear only

Do not use this product, unless directed by a doctor

•
if you have an injury or perforation (hole) of the ear drum
•
after ear surgery
•
for more than 4 days

Ask your doctor before use if you

•
have ear drainage or discharge
•
have ear pain, irritation or rash in the ear
•
feel dizzy

When using this product avoid contact with the eyes

Keep out of the reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions

for adults and children 12 years and over, or as directed by a doctor:

•
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 keeping head tilted or placing cotton in ear.
•
use twice daily for up to 4 days if needed
•
use a soft, rubber bulb ear syringe to gently flush ear with warm water to remove any wax remaining after treatment

Children under 12 years, consult a doctor.

Other information

•
store at 20°-25°C
•
avoid exposure to excessive heat and direct sunlight
•
keep tightly closed
•
see carton or label for lot number and expiration date.
•
TAMPER-EVIDENT: Do not use this product if the imprinted platic seal around the cap of the bottle is cut, torn, broken or missing.

Inactive Ingredients

citric acid anhydrous, glycerine, propylene glycol, purified water, sodium acid pyrophosphate, sodium citrate dihydrate, triethanolamine

Questions or comments?

1-800-645-2158

Distributed by:
Rugby Laboratories
31778 Enterprise Drive
Livonia, MI 48150

Repackaged By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

COMPARE TO
ACTIVE INGREDIENT IN
DEBROX®*

Rugby ®

NDC 68788-6439-1

TAMPER EVIDENT

Earwax
Treatment
Drops

Carbamide Peroxide 6.5%

Helps Remove
Excessive Earwax

1/2 fl oz (15 mL)

Repackaged By: Preferred Pharmaceuticals Inc.

Ear Drops Carbamide Peroxide 6.5 percent
EARWAX TREATMENT DROPS 
carbamide peroxide solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-6439(NDC:0536-1012)
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)  
Anhydrous Citric Acid (UNII: XF417D3PSL)  
Glycerin (UNII: PDC6A3C0OX)  
Sodium Acid Pyrophosphate (UNII: H5WVD9LZUD)  
Trisodium Citrate Dihydrate (UNII: B22547B95K)  
Propylene Glycol (UNII: 6DC9Q167V3)  
Trolamine (UNII: 9O3K93S3TK)  
Product Characteristics
ColorYELLOW (Colorloess to pale Yellow) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-6439-115 mL in 1 BOTTLE; Type 0: Not a Combination Product07/20/201611/10/2020
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34407/20/201611/10/2020
Labeler - Preferred Pharmaceuticals Inc. (791119022)
Registrant - Preferred Pharmaceuticals Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals Inc.791119022REPACK(68788-6439)

Revised: 11/2020
Document Id: 107b5a32-577f-4153-a28e-8d62b9568e69
Set id: 7006b786-ec05-44b1-b5b2-be07bc2219da
Version: 5
Effective Time: 20201110
 
Preferred Pharmaceuticals Inc.