EAR CLEANSING- alcohol, lactic acid, benzoic acid, and salicylic acid liquid

Ear Cleansing by

Drug Labeling and Warnings

Ear Cleansing by is a Animal medication manufactured, distributed, or labeled by Tomlyn Products, a Division of Vetoquinol USA, Inc., Vetoquinol USA, Inc., Vetoquinol N.-A. INC, Solvay USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

Tomlyn's Veterinarian Formulated Ear Cleaner is specially formulated to deodorize and gently clean, dry and acidify the external ear canal. This provides an environment which promotes maintenance of healthy ears, and aids in the prevention of external ear infections.

DOSAGE & ADMINISTRATION

DIRECTIONS: Apply liberally into the ear canal. Massage the base of the ear. Allow pet to shake head. Wipe excess away with a cotton ball. For very dirty ears, apply 2-3 times daily for several days. Do not use longer than 7 consecutive days without consulting a veterinarian. For routine cleaning and maintenance of healthy ears, use 1-2 times weekly, or as often as recommended by your veterinarian. Always apply after swimming.

SPL UNCLASSIFIED SECTION

ACTIVE INGREDIENTS (w/v): SD-Alcohol 40-2, 10%; Lactic Acid, 1.76%; Benzoic Acid, 0.15%; Salicyclic Acid, 0.1%.

SPL UNCLASSIFIED SECTION

INACTIVE INGREDIENTS: A fragrant base containing Aloe Vera Gel.

PRECAUTIONS

CAUTION: Consult your veterinarian if pet shakes head or scratches ears frequently. If redness or irritation develops or persists, discontinue use and consult your veterinarian. For topical use only. Avoid contact with eyes.

STORAGE AND HANDLING

STORAGE: Store at room temperature between 15°C and 25°C.

SPL UNCLASSIFIED SECTION

100% SATISFACTION GUARANTEED!

Questions?

Made in Canada by Vetoquinol N.-A. Inc.
Princeville, Quebec, Canada
Distributed by Tomlyn® Products
Division of Vetoquinol USA, Inc.
Ft. Worth, TX (USA) 76137
www.tomlyn.com

442064
101029

since 1976
tomlyn®
VETERINARY SCIENCE

Division of a worldwide veterinary health company

PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

since 1976
tomlyn®
VETERINARY SCIENCE

VETERINARIAN FORMULATED
EAR CLEANER
FOR DOGS & CATS

• Scientifically developed formula
• Dries, acidifies and deodorizes ears
• Gentle enough for routine use

DOGS
& CATS

Trusted since 1976.

NET WEIGHT:
4 fl oz (118 mL)

INGREDIENTS AND APPEARANCE

EAR CLEANSING 
alcohol, lactic acid, benzoic acid, and salicylic acid liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 47171-234
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Alcohol (UNII: 3K9958V90M) (Alcohol - UNII:3K9958V90M)	Alcohol	11.08 mL  in 1 mL
LACTIC ACID, UNSPECIFIED FORM (UNII: 33X04XA5AT) (LACTIC ACID, UNSPECIFIED FORM - UNII:33X04XA5AT)	LACTIC ACID, UNSPECIFIED FORM	17.6 mg  in 1 mL
Benzoic Acid (UNII: 8SKN0B0MIM) (Benzoic Acid - UNII:8SKN0B0MIM)	Benzoic Acid	1.5 mg  in 1 mL
Salicylic Acid (UNII: O414PZ4LPZ) (Salicylic Acid - UNII:O414PZ4LPZ)	Salicylic Acid	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
Tert-Butyl Alcohol (UNII: MD83SFE959)
Brucine Sulfate (UNII: KY7O12XPOQ)
Water (UNII: 059QF0KO0R)
Propylene Glycol (UNII: 6DC9Q167V3)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Docusate Sodium (UNII: F05Q2T2JA0)
Glycerin (UNII: PDC6A3C0OX)
Benzyl Alcohol (UNII: LKG8494WBH)

Product Characteristics
Color	WHITE	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47171-234-04	118 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/18/2016

Labeler - Tomlyn Products, a Division of Vetoquinol USA, Inc. (037730194)

Registrant - Vetoquinol USA, Inc. (106824209)

Establishment
Name	Address	ID/FEI	Business Operations
Vetoquinol N.-A. INC		202919940	MANUFACTURE

Establishment
Name	Address	ID/FEI	Business Operations
Solvay USA, Inc.		154210488	API MANUFACTURE