ANTIBACTERIAL AND ANTIFUNGAL MEDICATED TRIS FLUSH- ketoconazole solution

ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH by

Drug Labeling and Warnings

ANTIBACTERIAL and ANTIFUNGAL MEDICATED TRIS FLUSH by is a Animal medication manufactured, distributed, or labeled by Alpha Paw Inc, Tropichem Research Labs, LLC dba Vetio, Piramal Pharma Limited, Sharon Bio-Medicine Limited. Drug facts, warnings, and ingredients follow.

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

ALPHA PAW
Questions or Comments:
Call (800) 363-5458
www.alphapaw.com
Alpha Paw LLC, Las Vegas NV 89139

Packaging

Package 12oz 355mL

INGREDIENTS AND APPEARANCE

ANTIBACTERIAL AND ANTIFUNGAL MEDICATED TRIS FLUSH 
ketoconazole solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 86175-005
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: 86175-005-12	355 mL in 1 CONTAINER
2	NDC: 86175-005-24	1 in 1 PACKAGE
2		355 mL in 1 CONTAINER; Number of Units = 2

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/03/2022

Labeler - Alpha Paw Inc (117036685)

Establishment
Name	Address	ID/FEI	Business Operations
Tropichem Research Labs, LLC dba Vetio		603123068	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Piramal Pharma Limited		919067108	api manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Sharon Bio-Medicine Limited		675472749	api manufacture