CHLORHEXIDINE- chlorhexidine gluconate, salicyloyl phytosphingosine shampoo 
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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CHLORHEXIDINE 4% +PS SHAMPOO

ACTIVE INGREDIENTS: Chlorhexidine Gluconate 4%, Phytosphingosine Salicyloyl 0.05%.

INACTIVE INGREDIENTS: Water, Lauramine Oxide, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Disodium Oleamido MIPA Sulfosuccinate, Decyl Glucoside, Glycolic Acid, Fragrance, Tetrasodium EDTA, Methylchloroisothiazolinone, Methylisothiazolinone,  Magnesium Chloride, Magnesium Nitrate, Yellow No. 6.

PROPERTIES: Chlorhexidine 4% +PS Shampoo is a pleasantly scented shampoo designed for antiseptic cleansing of the skin of dogs and cats. It is soap-free and contains mild cleansing bases. Chlorhexidine 4% +PS Shampoo contains phytosphingosine, a Ceva-exclusive pro-ceramide to  help support a healthy skin barrier.

INDICATIONS: For use on dogs and cats only. For the management of skin infections that are responsive to chlorhexidine.

DIRECTIONS FOR USE: Wet the animal with warm water and apply Chlorhexidine 4% +PS Shampoo. Massage shampoo into wet hair coat. Allow to remain on hair for 5 to 10 minutes before rinsing thoroughly with clean water. Repeat if needed. Apply 3 times per week for 2 to 3 weeks or as directed by your veterinarian. May be used as part of a management plan as recommended by your veterinarian.

CAUTIONS: For external use on dogs and cats only. Avoid contact with 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 reach of children.

STORAGE CONDITIONS: 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 - 8 OUNCE (237 mL) Bottle

CHLORHEXIDINE 4% +PS

SHAMPOO

Chlorhexidine Gluconate 4%, Phytosphingosine salicyloyl 0.05%

Dogs • Cats

Antiseptic Shampoo

Phytosphingosine

8 FL. OZ. (237 mL)

Ceva

8 ounce bottle label

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

CHLORHEXIDINE 4% +PS

SHAMPOO

Chlorhexidine Gluconate 4%, Phytosphingosine Salicyloyl 0.05%

Dogs • Cats

Antiseptic Shampoo

Phytosphingosine

16 FL. OZ. (473 mL)

Ceva

16 ounce bottle label

PRINCIPAL DISPLAY PANEL - 1 Gallon Jug

CHLORHEXIDINE 4% +PS

SHAMPOO

Chlorhexidine Gluconate 4%, Phytosphingosine Salicyloyl 0.05%

Dogs • Cats

Antiseptic Shampoo

Phytosphingosine

1 Gallon

Ceva

1 gallon jug label

CHLORHEXIDINE 
chlorhexidine gluconate, salicyloyl phytosphingosine shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13744-103
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE40 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)  
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)  
DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F)  
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)  
GLYCOLIC ACID (UNII: 0WT12SX38S)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13744-103-01237 mL in 1 BOTTLE, PLASTIC
2NDC:13744-103-02473 mL in 1 BOTTLE, PLASTIC
3NDC:13744-103-033785 mL in 1 JUG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/01/201507/17/2019
Labeler - Ceva Sante Animale (261126049)
Registrant - Ceva Sante Animale (261126049)

Revised: 7/2019
 
Ceva Sante Animale