ANTIBACTERIAL AND ANTIFUNGAL MEDICATED TRIS FLUSH- ketoconazole solution 
Alpha Paw 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.

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ANTIBACTERIAL & ANTIFUNGAL MEDICATED TRIS FLUSH

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

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.

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

Package 12oz 355mL

ANTIBACTERIAL AND ANTIFUNGAL MEDICATED TRIS FLUSH 
ketoconazole solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:86175-005
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE0.1 g  in 100 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
ALCOHOL (UNII: 3K9958V90M)  
NONOXYNOL-9 (UNII: 48Q180SH9T)  
EDETATE DISODIUM ANHYDROUS (UNII: 8NLQ36F6MM)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
TROMETHAMINE (UNII: 023C2WHX2V)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:86175-005-12355 mL in 1 CONTAINER
2NDC:86175-005-241 in 1 PACKAGE
2355 mL in 1 CONTAINER; Number of Units = 2
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/03/2022
Labeler - Alpha Paw Inc (117036685)
Establishment
NameAddressID/FEIBusiness Operations
Tropichem Research Labs, LLC dba Vetio603123068manufacture
Establishment
NameAddressID/FEIBusiness Operations
Piramal Pharma Limited919067108api manufacture
Establishment
NameAddressID/FEIBusiness Operations
Sharon Bio-Medicine Limited675472749api manufacture

Revised: 3/2023
Document Id: 96b34a4e-a97b-4ffa-b997-9ec0fc441861
Set id: aef2cb97-c062-46ff-b7fa-16205f1ce508
Version: 1
Effective Time: 20230322
 
Alpha Paw Inc