KETOTRIS PS FLUSH- ketoconazole and phytosphingosine hydrochloride solution 
Sogeval Laboratories

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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KetoTRIS + PS FLUSH SOLUTION

KETO-TRIS +PS FLUSH

Ketconazole 0.1%, Tris-EDTA, Phytosphingosine 0.01%

Topical Antiseptic Solution for Cleansing and Flushing of Ears and Skin.

Ingredients:

Ketoconazole 0.1%, Phytosphingosine-HCl 0.01%, Tromethamine (Tris), Ethylenediaminetetraacetic acid (EDTA) in a pH 8 buffered solution.

Properties:

Keto-TRIS +PS Flush is an antiseptic (antibacterial and antifungal) solution for gentle cleansing and flushing of ears and skin. Contains ketoconazole for the management of yeasts and fungi and preservatives for antibacterial activity. Phytosphingosine is a pro-ceramide to restore the skin barrier and help in the long-term management of skin conditions. Phytosphingosine HCl also has antiseptic properties. The alkaline pH of Keto-TRIS +PS Flush helps potentiate local antibiotics such as quinolones and aminoglycosides. Can be used on dogs, cats and horses.

Available Through Licensed Veterinarians Only

Directions for Use:

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

Storage:

Store at controlled room temperature; protect from freezing.

Questions? Contact Sogeval Laboratories, Inc., Oldsmar, FL, 1-800-877-0177

PRINCIPAL DISPLAY PANEL - 4 OUNCE (119 mL) Bottle

SOGEVAL

Shared solutions

KETO-TRIS +PS

FLUSH

Ketconazole 0.1%, Tris-EDTA, Phytosphingosine 0.01%

Topical Antiseptic Solution for Cleansing and Flushing of Ears and Skin.

CONTAINS PS

PhytoSphingosine

Restores the Lipid Barrier

4 FL. OZ. (119 mL)

4 ounce KetoTRIS Label

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

SOGEVAL

Shared solutions

KETO-TRIS +PS

FLUSH

Ketconazole 0.1%, Tris-EDTA, Phytosphingosine 0.01%

Topical Antiseptic Solution for Cleansing and Flushing of Ears and Skin.

CONTAINS PS

PhytoSphingosine

Restores the Lipid Barrier

8 FL. OZ. (237 mL)

8 Ounce KetoTRIS Label

PRINCIPAL DISPLAY PANEL - 16 OUNCE (463 mL) Bottle

SOGEVAL

Shared solutions

KETO-TRIS +PS

FLUSH

Ketconazole 0.1%, Tris-EDTA, Phytosphingosine 0.01%

Topical Antiseptic Solution for Cleansing and Flushing of Ears and Skin.

CONTAINS PS

PhytoSphingosine

Restores the Lipid Barrier

16 FL. OZ. (473 mL)

16 ounce KetoTRIS Label

KETOTRIS PS FLUSH 
ketoconazole solution
Product Information
Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:59122-340
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
KETOCONAZOLE (KETOCONAZOLE) KETOCONAZOLE 1 mg  in 1 mL
PHYTOSPHINGOSINE HYDROCHLORIDE (PHYTOSPHINGOSINE) PHYTOSPHINGOSINE HYDROCHLORIDE 0.1 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
TROMETHAMINE  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:59122-340-03 118 mL in 1 BOTTLE, PLASTIC
2 NDC:59122-340-04 237 mL in 1 BOTTLE, PLASTIC
3 NDC:59122-340-05 473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/01/2014
Labeler - Sogeval Laboratories (963676635)
Registrant - Sogeval Labatories (963676635)

Revised: 4/2014
Document Id: 57aef723-7187-46f7-a7c3-ef85db36d4a3
Set id: bdeb34d4-8dc3-44b9-8134-0fe380bb27a7
Version: 1
Effective Time: 20140409
 
Sogeval Laboratories