Animal NDC 46066-079-91 Suffusion Tris

Ketoconazole

Animal Product Information

Field Name Field Value
Animal NDC Code 46066-079-91
Proprietary Name Suffusion Tris 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 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 Resources
Product Type Otc Animal Drug
Usage Information
    INDICATIONS: For use on dogs or cats for the antiseptic cleansing of skin and ears.DIRECTIONS FOR USE: Skin Cleaning: Apply twice a day or as directed by your veterinarian. Moisten absorbent material with solution and gently wipe the area to clean and remove debris. Repeat as necessary until clean. Wash hands after use.Ear Cleaning: Ask your veterinarian which of these protocols is best for your pet. 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. Wash hands after use.
Active Ingredient(s)
  • Ketoconazole
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • NONOXYNOL-9 (48Q180SH9T)
  • EDETATE DISODIUM (7FLD91C86K)
  • TROMETHAMINE (023C2WHX2V)
  • AVENANTHRAMIDES (5PA41O4AIT)
  • GLYCERIN (PDC6A3C0OX)
  • CERAMIDE 1 (5THT33P7X7)
  • CERAMIDE EOS (CR0J8RN66K)
  • CERAMIDE NP (4370DF050B)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • NONOXYNOL-9 (48Q180SH9T)
  • EDETATE DISODIUM (7FLD91C86K)
  • TROMETHAMINE (023C2WHX2V)
  • AVENANTHRAMIDES (5PA41O4AIT)
  • GLYCERIN (PDC6A3C0OX)
  • CERAMIDE 1 (5THT33P7X7)
  • CERAMIDE EOS (CR0J8RN66K)
  • CERAMIDE NP (4370DF050B)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • 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 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

FOR DOGS AND CATS

Ketoconazole 0.1%

ANTISEPTIC FLUSH

ACTIVE INGREDIENTS: Ketoconazole 0.1%.

INACTIVE INGREDIENTS: Water, SD Alcohol 40-B, Nonoxynol-9, Disodium EDTA, Tromethamine, Avena Sativa (Oat) Kernal Extract, Glycerin, Ceramide EOP, Ceramide EOS, Ceramide NP, Potassium Sorbate, Methylisothiazolinone.

PROPERTIES: A gentle antifungal and antibacterial skin and ear cleansing solution. Ketoconazole fights yeast and fungi. TRIS helps break down bacteria cell walls. Skin nourishing nutrients moisturize and calm the skin. They also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.


Indications & Usage



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

DIRECTIONS FOR USE: Skin Cleaning: Apply twice a day or as directed by your veterinarian. Moisten absorbent material with solution and gently wipe the area to clean and remove debris. Repeat as necessary until clean. Wash hands after use.

Ear Cleaning: Ask your veterinarian which of these protocols is best for your pet. 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. Wash hands after use.


Precautions



CAUTIONS: For external use on dogs and cats only. Avoid contact with the 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 in the case of a suspected ruptured eardrum.

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

pivetalvet.com


Principal Display Panel - 4 Ounce (118 Ml) Bottle



Pivetal

NDC 46066-079-88

Suffusion™ TRIS

FOR DOGS AND CATS

Ketoconazole 0.1%

ANTISEPTIC FLUSH

4 fl oz (118 mL)


Principal Display Panel - 16 Ounce (473 Ml) Bottle



Pivetal

NDC 46066-079-91

Suffusion™ TRIS

FOR DOGS AND CATS

Ketoconazole 0.1%

ANTISEPTIC FLUSH

16 fl oz (473 mL)


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