EAROXIDE EAR CLEANSER- carbamide peroxide liquid 
Tomlyn Products, a Division of Vetoquinol USA, Inc.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Earoxide™ by Tomlyn® ear cleanser is a safe and easy way to dissolve and wash away dirt and wax from your dog or cat's ears – instantly and painlessly.

DIRECTIONS

Clip ear hair and clean your pet's outer ear. Fill the ear canal with Earoxide™ and gently massage by pressing on the external ear canal. After a few minutes, you may release your pet and allow it to shake its head and throw out the dissolved material. Repeat daily until the ear canal is free of foreign material.

NO SWABBING OR PROBING OF THE EAR CANAL IS REQUIRED.

CAUTION

If draining or irritation persists, consult your veterinarian.

FOR ANIMAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN AND PETS.

INGREDIENTS

Contains carbamide peroxide 6.5% in a stabilized glycerin base.

STORE IN A COOL DRY PLACE. KEEP CAP TIGHTLY CLOSED.

Manufactured for:
Tomlyn® Products
Division of Vétoquinol USA, Inc.
Ft. Worth, TX (USA) 76137
www.tomlyn.com

0461
Made in USA
10
Lot No.
Exp.Date

PRINCIPAL DISPLAY PANEL - 118 ml Bag Label

tomlyn®

EAR

Earoxide™

PET EAR CLEANSER

Dissolves dirt & wax
Works instantly & painlessly

DOG & CAT

4 fl oz (118 ml)

PRINCIPAL DISPLAY PANEL - 118 ml Bag Label
EAROXIDE EAR CLEANSER 
carbamide peroxide liquid
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:47171-050
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Carbamide Peroxide (Hydrogen Peroxide) Carbamide Peroxide65 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
Glycerin 
Etidronate Tetrasodium 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:47171-050-0259 mL in 1 BOTTLE, PLASTIC
2NDC:47171-050-04118 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other12/29/1999
Labeler - Tomlyn Products, a Division of Vetoquinol USA, Inc. (037730194)
Registrant - Vetoquinol USA, Inc. (106824209)
Establishment
NameAddressID/FEIBusiness Operations
American Pharmaceuticals and Cosmetics, Inc.038023805MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
United Initiatiors GmbH & Co.KG315033134API MANUFACTURE

Revised: 05/2013
Document Id: ca4d982f-992b-4e6b-aa4b-5428c196b144
Set id: 69487a1d-6c3e-40a8-96c5-387c78dfe621
Version: 2
Effective Time: 20130508
 
Tomlyn Products, a Division of Vetoquinol USA, Inc.