0.1% KETOCONAZOLE, 0.15% SALICYLIC ACID- ear rinse solution, gel forming / drops 
Sergeant's Pet Care Products LLC

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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PetArmor Ear Rinse for dogs and cats

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

G002697-1 AMIA

image description

0.1% KETOCONAZOLE, 0.15% SALICYLIC ACID 
ear rinse solution, gel forming / drops
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:21091-697
Route of AdministrationAURICULAR (OTIC)
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE0.1 
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID0.15 
Inactive Ingredients
Ingredient NameStrength
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
ColorwhiteScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:21091-697-041 in 1 CONTAINER
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/08/201911/08/2023
Labeler - Sergeant's Pet Care Products LLC (876995171)
Establishment
NameAddressID/FEIBusiness Operations
DIVERSIFIED MANUFACTURING CORP185073996manufacture, label, pack
Establishment
NameAddressID/FEIBusiness Operations
Sharon Bio-Medicine Limited675472749api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Sigma-Aldrich Manufacturing LLC829643423api manufacture

Revised: 11/2023
 
Sergeant's Pet Care Products LLC