HYLIDERM PS- 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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Hyliderm+PS Shampoo

ACTIVE INGREDIENT: Phytosphingosine salicloyl 0.02%.

INACTIVE INGREDIENTS: Water, Sodium C14-16 Olefin Sulfonate, Cocamidopropyl Betaine, Disodium Cocoamphodiacetate, Sodium Lactate, Fragrance, Glycerin, Propylene Glycol, Hydroxypropyl Methylcellulose, Tetrasodium EDTA, Carthamus Tinctorius (Safflower) Seed Oil, Sodium Chloride, Citric Acid, Methylchloroisothiazoline, Methylisothiazolinone, Magnesium Nitrate, Magnesium Chloride.

PROPERTIES: Hyliderm +PS Shampoo is a gentle hypoallergenic and soap-free formulation for grooming and moisturizing. It contains emollients and fatty acids to soothe and nourish the skin, and aid in the control of flaking and skin irritations. Hyliderm +PS Shampoo also contains phytosphingosine, a Ceva exclusive pro-ceramide to help support a healthy skin barrier.

INDICATION: For use on dogs and cats only. For grooming and moisturizing of dry, sensitive skin.

DIRECTIONS FOR USE: Wet the animal with warm water and apply Hyliderm +PS Shampoo. Massage into the wet hair coat. Allow to remain on the hair coat for 5 to 10 minutes before rinsing thoroughly with clean water. Repeat if needed. Shampoo 2 to 3 times per week, for 3 to 4 weeks, 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 CONDITIONS: Store at room temperature. Do not freeze.

Authorized for sale through licensed veterianarians only.

Manufactured for Ceva Animal Health, LLC

Lenexa, KS 66215 ¦ 1-800-999-0297

©2015 Ceva Animal Health, LLC

PRINCIPAL DISPLAY PANEL - 2 OUNCE Bottle

Hyliderm+PS

Shampoo

Phytosphingosine salicloyl 0.02%

Dogs • Cats

Cucumber Melon Scent

Moisturizing Shampoo

Phytosphingosine

Net Content: 2 FL. OZ. (59 mL)

Sample Size

Ceva

Hyliderm 2 ounce bottle label

PRINCIPAL DISPLAY PANEL - 8 OUNCE BOTTLE

Hyliderm +PS

Shampoo

Phytosphingosine salicloyl 0.02%

Dogs • Cats

Cucumber Melon Scent

Moisturizing Shampoo

Phytosphingosine

Net Content: 8 FL. OZ. (237 mL)

Ceva

8 ounce bottle label

PRINCIPAL DISPLAY PANEL - 16 OUNCE BOTTLE

Hyliderm +PS

Shampoo

Phytosphingosine salicloyl 0.02%

Dogs • Cats

Cucumber Melon Scent

Moisturizing Shampoo

Phytosphingosine

Net Content: 16 FL. OZ. (473 mL)

Ceva

16 ounce bottle label

PRINCIPAL DISPLAY PANEL - 1 GALLON JUG

Hyliderm +PS

Shampoo

Phytosphingosine salicloyl 0.02%

Dogs • Cats

Cucumber Melon Scent

Moisturizing Shampoo

Phytosphingosine

1 GALLON

Ceva

1 gallonjug label

HYLIDERM PS 
salicyloyl phytosphingosine shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:13744-126
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE0.2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
GLYCERIN (UNII: PDC6A3C0OX)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
MAGNESIUM NITRATE (UNII: 77CBG3UN78)  
MAGNESIUM CHLORIDE (UNII: 02F3473H9O)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:13744-126-0160 mL in 1 BOTTLE, PLASTIC
2NDC:13744-126-02237 mL in 1 BOTTLE, PLASTIC
3NDC:13744-126-03473 mL in 1 BOTTLE, PLASTIC
4NDC:13744-126-043785 mL in 1 JUG
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/201607/19/2019
Labeler - Ceva Sante Animale (261126049)
Registrant - Ceva Sante Animale (261126049)

Revised: 7/2019
 
Ceva Sante Animale