0.1% Ketoconazole, 0.15% Salicylic Acid: Product Information

0.1% KETOCONAZOLE, 0.15% SALICYLIC ACID- ketoconazole and salicylic acid solution, gel forming / drops
Sergeant’s Pet Care Products 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.

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.

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

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

G002697 AVRV

image description
(click image for full-size original)
image description
(click image for full-size original)

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) DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 0.1
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 0.15
Inactive Ingredients
Ingredient Name Strength
WATER 80.1
PROPYLENE GLYCOL 10.0
GLYCERIN 5.0
POLYSORBATE 20 4.0
POTASSIUM SORBATE .20
SODIUM BENZOATE .15
Product Characteristics
Color white Score
Shape Size
Flavor Imprint Code
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:21091-697-04 1 SOLUTION, GEL FORMING / DROPS in 1 CONTAINER None
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 Operations
DIVERSIFIED MANUFACTURING CORP 080569998 manufacture, label, pack, relabel, repack
Establishment
Name Address ID/FEI Operations
Sharon Bio-Medicine Limited 918572723 api manufacture
Establishment
Name Address ID/FEI Operations
Shandong Xinhua Pharmaceutical Co. Ltd. 421295757 api manufacture

Revised: 10/2019 Sergeant’s Pet Care Products Inc.

VetLabel.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the U.S. Food and Drug Administration. Package information is not reviewed or updated separately by VetLabel.com. Every individual animal healthcare product label entry contains a unique identifier which can be used to secure further details directly from the U.S. National Institutes of Health and/or the FDA.

Our database mirrors the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. VetLabel.com provides the full animal health subset of the FDA's repository. Veterinary information provided here is not intended as a substitute for direct consultation with a qualified veterinary professional.

Terms of Use | Copyright © 2021. All Rights Reserved.