PHYTO CHX KET ANTISEPTIC MOUSSE- chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl liquid 
Butler Animal Health Supply, LLC dba Covetrus North America

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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PHYTO CHX+KET ANTISEPTIC MOUSSE

Active Ingredients: Chlorhexidine gluconate 2%, ketoconazole 1%, phytosphingosine salicyloyl 0.05%.

Inactive Ingredients: Water, propylene glycol, glycerin, polysorbate 20, lactic acid, fragrance, methylisothiazolinone.

Properties:Phyto CHX+KET antiseptic mousse is formulated with chlorexidine gluconate and ketoconazole, antibacterial and antifungal agents for the management of skin infections. This no-rinse mousse also contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.

Indications: For use on dogs and cats only. For the management of bacterial and fungal skin infections responsive to chlorhexidine gluconate and ketoconazole.

Directions for use: Shake well before use. Brush the fur then apply product on dry hair. Apply every 3 days for 2-3 weeks or as directed by your veterinarian.

For localized application: Dispense 1 to 2 pumps onto your palm, then apply on the targeted area(s). Massage into the skin until fully penetrated. Do not rinse, let air dry. Once dry, brush the fur again.

For whole body application: Dispense 1 to 2 pumps onto your palm and massage onto the skin. Repeat as many times as necessary to cover the whole body, avoiding the eyes and mouth. Do not rinse, let air dry. Once dry, brush the fur again.

Dosage:
Under 11 lbs: 1 pump per 2 lbs
11 - 88 lbs: 1 pump per 4 lbs
Over 88 lbs: 1 pump per 6 lbs

Dosage may be doubled for long-haired breeds.

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. Wash hands after use.

Storage: Store at room temperature. Do not freeze.

Questions? (855) 724-3461

Distributed by:
Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

PRINCIPAL DISPLAY PANEL - 6.8 fl oz (200 mL)

covetrus

NDC 11695-7232-2

Phyto CHX+KET

Chlorhexidine gluconate 2%, ketoconazole 1%,

phytosphingosine salicyloyl 0.05%

Antiseptic Mousse

Antiseptic mousse for dogs and cats

For animal use only

Keep out of reach of children

SHAKE WELL BEFORE USE

Net contents: 6.8 fl oz (200 mL)

200 mL bottle label

PHYTO  CHX KET ANTISEPTIC MOUSSE
chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl liquid
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7232
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
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
GLYCERIN (UNII: PDC6A3C0OX)  
LACTIC ACID (UNII: 33X04XA5AT)  
POLYSORBATE 20 (UNII: 7T1F30V5YH)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-7232-2200 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2020
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)
Establishment
NameAddressID/FEIBusiness Operations
Evonik Nutrition & Care GmbH314906476api manufacture

Revised: 11/2019
Document Id: 8317fb79-1857-44d1-9fd4-6ab968d0d274
Set id: f29a002f-1452-4605-9d82-d6d3e7aa8ecf
Version: 1
Effective Time: 20191114
 
Butler Animal Health Supply, LLC dba Covetrus North America