ANTIBACTERIAL AND ANTIFUNGAL MEDICATED TRIS FLUSH- ketoconazole solution

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENTS
Ketoconazole...............................................0.1%

PURPOSE

ANTIBACTERIAL & ANTIFUNGAL MEDICATED TRIS FLUSH For Dogs & Cats

FIGHT FUNGUS!

Say goodbye to pesky ear infections. Treatment is as easy as point, squeeze and soothe. Skin conditions that are responsive to Ketoconazole stand no chance against this powerful formula. Non-irritating formula ensures pets are comfortable.

INACTIVE INGREDIENTS

Water, SD Alcohol-40B, Nonoxynol-9, Disodium EDTA, Benzyl Alcohol, Fragrance, Tromethamine Technical Grade.

PRECAUTIONS

For topical use on animals only. Avoid contact with eyes, or mucous membranes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian. Do not allow the animal to directly inhale the spray. If undue skin irritation develops or increases, discontinue use and consult a veterinarian.

DIRECTIONS

Shake well before use. Apply liberally to the affected area(s). Apply twice daily or as directed by veterinarian. Use cotton or absorbent material to clean excess solution and wipe away debris. Do not allow the animal to lick the treated area until dry to prevent ingestion. Wash hands after use.

STORAGE

Store at controlled room temperature; protect from freezing.

SPL UNCLASSIFIED SECTION

Contains ketoconazole
Manages fungal activity
Gentle flushing of ears & skin
Antiseptic & antifungal solution

GENTLE ON SKIN
CHOSEN BY TOP VETS
FOR DOGS AND CATS

Smiling Paws Pets
5924 Sheridan St
Hollywood, FL 33021
www.smilingpawspets.com

Product label

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL AND ANTIFUNGAL MEDICATED TRIS FLUSH 
ketoconazole solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86255-004
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I)	KETOCONAZOLE	0.1 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
NONOXYNOL-9 (UNII: 48Q180SH9T)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
TROMETHAMINE (UNII: 023C2WHX2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86255-004-01	1 in 1 CONTAINER
1		355 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/01/2024

Labeler - Smiling Paws Pets LLC (838142813)