0.1% KETOCONAZOLE, 0.15% SALICYLIC ACID- ear rinse solution, gel forming / drops

0.1% Ketoconazole, 0.15% Salicylic Acid by

Drug Labeling and Warnings

0.1% Ketoconazole, 0.15% Salicylic Acid by is a Animal medication manufactured, distributed, or labeled by Sergeant's Pet Care Products Inc., DIVERSIFIED MANUFACTURING CORP, Sharon Bio-Medicine Limited, Shandong Xinhua Pharmaceutical Co. Ltd.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

PetArmor Ear Rinse

For Dogs and Cats

Aid in drying or cleansing

Gently cleans away dirt and was

PetArmor® Ear Rinse can be used for gentle flushing and cleansing of skin and ears in conditions where an antibacterial and antifungal formulation is indicated. It also lowers the pH in the ear to inhibit bacterial growth.

ACTIVE INGREDIENTS:

0.1% Ketoconazole, 0.15% Salicylic Acid

INACTIVE INGREDIENTS:

Purified Water, Propylene Glycol, Glycerin, Polysorbate 20, Fragrance, Potassium Sorbate, Sodium Benzoate

Directions for Use:

SHAKE WELL. For use as an ear flush: apply to the ear canal and gently, but firmly, massage the base of the ear. Use a cotton ball to remove excess solution. Repeat as necessary or as directed by your veterinarian. Close cap tightly for storage.

CAUTION:

For topical use only. Do not use on severely irritated skin – contact your veterinarian. If skin irritation develops or increases or you see no
improvement, stop use and call your veterinarian.  Keep out of reach of children and pets. Wash hands after use.

STORAGE AND HANDLING

Store at controlled room temperature of 15 - 30° C (59 - 86° F).

QUESTIONS

Questions or medical emergency: 1-800-224-7387

G002697 AVRV

INGREDIENTS AND APPEARANCE

0.1% KETOCONAZOLE, 0.15% SALICYLIC ACID 
ear rinse solution, gel forming / drops

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 21091-697
Route of Administration	AURICULAR (OTIC)

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	0.1
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	0.15

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)	80.1
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	10.0
GLYCERIN (UNII: PDC6A3C0OX)	5.0
POLYSORBATE 20 (UNII: 7T1F30V5YH)	4.0
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)	.20
SODIUM BENZOATE (UNII: OJ245FE5EU)	.15

Product Characteristics
Color	white	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 21091-697-04	1 in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/08/2019

Labeler - Sergeant's Pet Care Products Inc. (876995171)

Establishment
Name	Address	ID/FEI	Business Operations
DIVERSIFIED MANUFACTURING CORP		080569998	manufacture, label, pack, relabel, repack

Establishment
Name	Address	ID/FEI	Business Operations
Sharon Bio-Medicine Limited		918572723	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Shandong Xinhua Pharmaceutical Co. Ltd.		421295757	api manufacture