KETOSEB by Ceva Sante Animale

KETOSEB by

Drug Labeling and Warnings

KETOSEB by is a Animal medication manufactured, distributed, or labeled by Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KETOSEB- chlorhexidine gluconate, ketoconazole, phytosphingosine salicloyl solution 
Ceva Sante Animale

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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Ketoseb +PS Flush

Topical Antiseptic Flushing Solution

ACTIVE INGREDIENTS: Chlorhexidine Gluconate 0.2%, Ketoconazole 0.2%, Phytosphingosine salicyloyl 0.02%.

INACTIVE INGREDIENTS: Water, Propylene Glycol, Nonoxynol-12, Glycerin, Polysorbate 20, Dioctyl Sodium Sulfosuccinate, Lactic Acid, Fragrance, Benzyl Alcohol, Aloe Barbadenis Leaf Juice.

PROPERTIES: Ketoseb +PS Flush is a solution designed for the antiseptic cleansing of the skin on dogs and cats. It is rubbing alcohol free and moisturizing. Ketoseb +PS Flush also contains phytosphingosine, a Ceva exclusive pro-ceramide to help support a healthy skin barrier.

INDICATIONS: For use on dogs and cats only. For antiseptic cleansing of puncture wounds, lacerations and abrasions. May also be used for the management of localized skin infections that are responsive to chlorhexidine and ketoconazole. 

DIRECTIONS FOR USE: Apply Ketoseb +PS Flush liberally to affected area. Use cotton or absorbent material to clean the excess solution. Do not allow the animal to lick the treated area until dry. Apply twice a day or as directed by your veterinarian.

CAUTIONS: For external use on dogs and cats only. Avoid contact with the eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.

WARNING: Keep out of the reach of children.

STORAGE: Store at room temperature. Do not freeze.

Authorized for sale through licensed veterinarians only.

Manufactured for Ceva Animal Health, LLC

Lenexa, KS 66215 ¦ 1-800-999-0297

©2015 Ceva Animal Health, LLC

PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle

Ketoseb +PS

FLUSH

Chlorhexidine Gluconate 0.2%, Ketoconazole 0.2%,

Phytosphingosine salicyloyl 0.02%

Dogs Cats

Topical Antiseptic

Flushing Solution

Phytosphingosine

Net Content: 4 FL. OZ. (118 mL)

Ceva

image description

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

Ketoseb +PS

FLUSH

Chlorhexidine Gluconate 0.2%, Ketoconazole 0.2%,

Phytosphingosine salicloyl 0.02%

Dogs Cats

Topical Antiseptic Flushing Solution

Phytosphingosine

Net Content: 16 FL. OZ. (473 mL)

Ceva

16 ounce bottle label

KETOSEB 
chlorhexidine gluconate, ketoconazole, phytosphingosine salicloyl solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC: 13744-110
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE2 mg  in 1 mL
KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE2 mg  in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
NONOXYNOL-12 (UNII: 6NR43D77O6)  
GLYCERIN (UNII: PDC6A3C0OX)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
DI-N-OCTYL SODIUM SULFOSUCCINATE (UNII: 4YLY5570Y0)  
LACTIC ACID (UNII: 33X04XA5AT)  
BENZYL ALCOHOL (UNII: LKG8494WBH)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 13744-110-01118 mL in 1 BOTTLE, PLASTIC
2NDC: 13744-110-02473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/201611/01/2019
Labeler - Ceva Sante Animale (261126049)
Registrant - Ceva Sante Animale (261126049)

Revised: 11/2019
 
Ceva Sante Animale