Animal NDC 46066-166-80 Suffusion Tris Flush

Ketoconazole, Phytosphingosine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 46066-166-80
Proprietary Name Suffusion Tris Flush What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Ketoconazole, Phytosphingosine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Aspen Veterinary Resource, Ltd.
Product Type Otc Animal Drug
Usage Information
    INDICATIONS: For the antiseptic cleansing of skin and ears on dogs and cats.DIRECTIONS FOR USE: Shake well before use. Apply twice a day or as directed by your veterinarian. Ask your veterinarian which of the following protocols is best for your pet.Ear cleaning: 1) Moisten a cotton ball with solution and place in entrance of ear canal; OR 2) Hold the ear flap upwards and fill the ear canal with solution. Then gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away debris and excess solution with a clean, dry cotton ball. Skin cleaning: Apply liberally then use absorbent material to gently wipe away excess solution and debris. Repeat as necessary until clean. Do not allow animal to lick the treated area.
Active Ingredient(s)
  • Ketoconazole
  • Phytosphingosine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • NONOXYNOL-9 (48Q180SH9T)
  • TROMETHAMINE (023C2WHX2V)
  • EDETATE DISODIUM (7FLD91C86K)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • NONOXYNOL-9 (48Q180SH9T)
  • TROMETHAMINE (023C2WHX2V)
  • EDETATE DISODIUM (7FLD91C86K)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Suffusion Tris Flush Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



Description



Suffusion TRIS +PS FLUSH

ACTIVE INGREDIENTS: Ketoconazole 0.1%, Phytosphingosine HCl 0.01%.

INACTIVE INGREDIENTS: Water, SDA 40B 190 Proof, Nonoxynol-9, Disodium EDTA, Tromethamine, Methylisothiazolinone.

PROPERTIES: Suffusion TRIS +PS Flush is an antibacterial and antifungal solution for the gentle cleansing of skin and ears. It contains ketoconazole for the management of yeast and fungal infections. TRIS +PS Flush helps break down bacteria cell walls. It also contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.


Indications & Usage



INDICATIONS: For the antiseptic cleansing of skin and ears on dogs and cats.

DIRECTIONS FOR USE: Shake well before use. Apply twice a day or as directed by your veterinarian. Ask your veterinarian which of the following protocols is best for your pet.
Ear cleaning: 1) Moisten a cotton ball with solution and place in entrance of ear canal; OR 2) Hold the ear flap upwards and fill the ear canal with solution. Then gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away debris and excess solution with a clean, dry cotton ball. Skin cleaning: Apply liberally then use absorbent material to gently wipe away excess solution and debris. Repeat as necessary until clean. Do not allow animal to lick the treated area.


Precautions



CAUTIONS: For external use on dogs and cats only. Avoid contact with eyes. If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Do not use with a suspected ruptured eardrum. Wash hands after use.

WARNING: Keep out of reach of children.


Storage And Handling



STORAGE CONDITIONS: Store at room temperature. Do not freeze.


Other



QUESTIONS? 1-800-999-0297

Pivetal

Distributed by:

Aspen Veterinary Resources®, LTD.
Liberty, MO 64068
www.pivetalvet.com


Principal Display Panel - 4 Ounce (118 Ml) Bottle



NDC 46066-166-80

SUFFUSION™

TRIS +PS Flush

Ketoconazole 0.1%,

Phytosphingosine HCl 0.01%

Antiseptic Solution

FOR DOGS & CATS

Phytosphingosine

Wellness

• BY PIVETAL •

4 FL. OZ. (118 mL)


Principal Display Panel - 16 Ounce (473 Ml) Bottle



NDC 46066-166-91

SUFFUSION™

TRIS +PS Flush

Ketoconazole 0.1%,

Phytosphingosine HCl 0.01%

Antiseptic Solution

FOR DOGS & CATS

Phytosphingosine

Wellness

• BY PIVETAL •

16 FL. OZ. (473 mL)


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.