TRUSEB ANTISEPTIC TRIS EAR FLUSH FOR DOGS AND CATS- ketoconazole solution

Drug Labeling and Warnings

Drug Details [pdf]

ACTIVE INGREDIENT:

Ketoconazole 0.1%

INDICATIONS & USAGE:

Truseb™ tris ear flush is pleasantly scented with a refreshing cucumber melon fragrance for general cleansing, flushing and soothing formulation designed for dogs, cats & horses.

INACTIVE INGREDIENT:

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

DOSAGE & ADMINISTRATION:

Directions for use: 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.

PRECAUTIONS:

Cautions: For animal use only. For topical use only. Avoid contact with eyes or mucous membranes. If undue skin irritation develops or increases, discontinue use and consult your veterinarian. In case of contact, flush eyes with water and seek medical attention if undue irritation persists. Keep out of the reach of children.

STORAGE AND HANDLING:

Storage: Store at controlled room temperature

SPL UNCLASSIFIED SECTION:

Otic

Cleaning

Deodorizing

Soothing

Antiseptic Tris Ear Flush

SOLUTION FOR CLEANSING & FLUSHING OF EARS AND SKIN

FOR DOGS & CATS

ANTIMICROBIAL

CUCUMBER MELON SCENT

MADE IN THE USA

ADVANCED VETERINARY FORMULA
Broad Spectrum

Distributed by:
Pet Health Pharma, Inc
7726 N Frst St, Suite 272
Fresno , CA 93720
(1)-559-900-7038
pethealthpharma.com

SPL UNCLASSIFIED SECTION

PRINCIPAL DISPLAY PANEL

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INGREDIENTS AND APPEARANCE

TRUSEB ANTISEPTIC TRIS EAR FLUSH FOR DOGS AND CATS 
ketoconazole solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86176-208
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)
BENZYL ALCOHOL (UNII: LKG8494WBH)
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)
TROMETHAMINE (UNII: 023C2WHX2V)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 86176-208-04	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 86176-208-08	237 mL in 1 BOTTLE, PLASTIC
3	NDC: 86176-208-12	355 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/26/2026

Labeler - Pet Health Pharma, LLC (100789128)