Animal NDC 46066-058-91 Suffusion K

Chlorhexidine Gluconate, Ketoconazole

Animal Product Information

Field Name Field Value
Animal NDC Code 46066-058-91
Proprietary Name Suffusion K 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 Chlorhexidine Gluconate, 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 Resource, Ltd.
Product Type Otc Animal Drug
Usage Information
    INDICATIONS: For use on dogs and cats with skin infections that are responsive to chlorhexidine gluconate and ketoconazole.DIRECTIONS FOR USE:Bathe 2 to 3 times per week until symptoms subside or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply shampoo first on the skin abnormalities. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water. Wash hands after use. For a rinse-free solution between baths, ask your veterinarian about Suffusion™ K Wipes, Suffusion™ K Spray, or Suffusion™ K Mousse.
Active Ingredient(s)
  • Chlorhexidine Gluconate
  • Ketoconazole
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • LAURAMINE OXIDE (4F6FC4MI8W)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (0A5MM307FC)
  • DECYL GLUCOSIDE (Z17H97EA6Y)
  • GLYCOLIC ACID (0WT12SX38S)
  • AVENANTHRAMIDES (5PA41O4AIT)
  • GLYCERIN (PDC6A3C0OX)
  • CERAMIDE 1 (5THT33P7X7)
  • CERAMIDE EOS (CR0J8RN66K)
  • CERAMIDE NP (4370DF050B)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • EDETATE SODIUM (MP1J8420LU)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • WATER (059QF0KO0R)
  • LAURAMINE OXIDE (4F6FC4MI8W)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (0A5MM307FC)
  • DECYL GLUCOSIDE (Z17H97EA6Y)
  • GLYCOLIC ACID (0WT12SX38S)
  • AVENANTHRAMIDES (5PA41O4AIT)
  • GLYCERIN (PDC6A3C0OX)
  • CERAMIDE 1 (5THT33P7X7)
  • CERAMIDE EOS (CR0J8RN66K)
  • CERAMIDE NP (4370DF050B)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • EDETATE SODIUM (MP1J8420LU)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • 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 K 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 K Shampoo

ACTIVE INGREDIENTS: Chlorhexidine Gluconate 2%, Ketoconazole 1%.

INACTIVE INGREDIENTS:

Water, Lauramine Oxide, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Decyl Glucoside, Glycolic Acid, Avena Sativa (Oat) Kernel Extract, Glycerin, Ceramide EOP, Ceramide EOS, Ceramide NP, Potassium Sorbate, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone.

PROPERTIES:

Suffusion™ K Shampoo is a shampoo with chlorhexidine and ketoconazole, antibacterial and antifungal ingredients for antiseptic skin cleansing. 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 and cats with skin infections that are responsive to chlorhexidine gluconate and ketoconazole.

DIRECTIONS FOR USE:

Bathe 2 to 3 times per week until symptoms subside or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply shampoo first on the skin abnormalities. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water. Wash hands after use. For a rinse-free solution between baths, ask your veterinarian about Suffusion™ K Wipes, Suffusion™ K Spray, or Suffusion™ K Mousse.


Warnings And 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.

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 - 8 Ounce (237 Ml) Bottle



Pivetal®

NDC 46066-058-90

SUFFUSION™ K

FOR DOGS AND CATS

Chlorhexidine Gluconate 2%, Ketoconazole 1%

ANTISEPTIC SHAMPOO

ANTIBACTERIAL

ANTIFUNGAL

8 fl oz (237 mL)


Principal Display Panel - 16 Ounce (473 Ml) Bottle



Pivetal®

NDC 46066-058-90

SUFFUSION™ K

FOR DOGS AND CATS

Chlorhexidine Gluconate 2%, Ketoconazole 1%

ANTISEPTIC SHAMPOO

ANTIBACTERIAL

ANTIFUNGAL

16 fl oz (473 mL)


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