SUFFUSION K- chlorhexidine gluconate, ketoconazole shampoo 
Aspen Veterinary Resource, LTD.

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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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: 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.

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 CONDITIONS: Store at room temperature. Do not freeze.

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)

8 ounce bottle label

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)

16 ounce bottle label

SUFFUSION  K
chlorhexidine gluconate, ketoconazole shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-058
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE20 mg  in 1 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
AVENANTHRAMIDES (UNII: 5PA41O4AIT)  
GLYCERIN (UNII: PDC6A3C0OX)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
CERAMIDE EOS (UNII: CR0J8RN66K)  
CERAMIDE NP (UNII: 4370DF050B)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
EDETATE SODIUM (UNII: MP1J8420LU)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46066-058-90237 mL in 1 BOTTLE, PLASTIC
2NDC:46066-058-91473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/09/2021
Labeler - Aspen Veterinary Resource, LTD. (627265361)
Registrant - Ceva Sante Animale (261126049)

Revised: 4/2021
Document Id: 1e5ec23c-8837-47e6-aa73-cb0ac215889a
Set id: 7936df5e-da67-417e-a445-cba5cc7fe6d8
Version: 1
Effective Time: 20210407
 
Aspen Veterinary Resource, LTD.