KETOMAX TRIS FLUSH- ketoconazole solution

Ketomax TRIS FLUSH by

Drug Labeling and Warnings

Ketomax TRIS FLUSH by is a Animal medication manufactured, distributed, or labeled by Animal Pharmaceuticals, Stratford Care Usa, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active Ingredients

Ketoconazole, USP 0.1%

Purpose

Antifungal

Inactive Ingredients

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

Uses:

a medicated cleansing solution with antimicrobial and antifungal activity for dogs and cats.

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

For topical use in animals only. Avoid contact with eyes. If eye contact occurs, rinse thoroughly with water and consult a veterinarian.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children. In case of contact with eyes or mucous membranes, flush with copious amounts of water for 5-10 minutes. If irritation persists seek medical attention immediately.

SPL UNCLASSIFIED SECTION

A Ready-To-Use Antimicrobial and Antifungal Cleansing Solution.

Formulated for Dogs and Cats

At Animal Pharmaceuticals we strive to provide the best nutritional and topical treatments for your pet by going above and beyond....and we don't stop there. We know that caring for your pet is just as important as caring for your own health, so we've developed and implemented systems that make things easier on you and convenient for your Veterinarian.

OUR ASSURANCE
Animal Pharmaceuticals products are designed with our proprietary technology that helps retrieve and sustain the nutrients and healthful ingredients. Our proprietary formulation enhances the effects of functional ingredients and penetrates the skin and the effective areas to exert the corrective results.

Additionally, and as always, you'll find that all our bottles and containers are made of recyclable plastic. Please help us protect the environment by recycling.

ALL PRODUCTS ARE MADE IN THE U.S.A. AND 100% QUALITY GUARANTEED.

To learn more about our products, visit:

www.anmpharm.com

SOLD EXCLUSIVELY THROUGH LICENSED VETERINARIANS

MANUFACTURED FOR
Animal Pharmaceuticals

MADE IN THE USA

Packaging

INGREDIENTS AND APPEARANCE

KETOMAX TRIS FLUSH 
ketoconazole solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 68898-120
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: 68898-120-08	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 68898-120-12	355 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/15/2021

Labeler - Animal Pharmaceuticals (166472444)

Registrant - Stratford Care Usa, Inc. (036650469)