SKINGUARD BALANCE MOUSSE- phytosphingosine hydrochloride liquid 
Vicar Operating Inc.

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.

----------

SkinGuard® Balance Mousse

Soap-free mousse helps restore the skin’s natural moisture balance and clear dryness and flakiness

ACTIVE INGREDIENT: Phytosphingosine HCl 0.2%

INACTIVE INGREDIENTS: Water, PEG/PPG/Polybutylene Glycol - 8/5/3 Glycerin, Glycerin, Panthenol, Sodium Lactate, Butylene Glycol, Capryl/Capramidopropyl Betaine, Polyglyceryl-10 Laurate, Dipropylene Glycol, Boswellia Serrata Gum Extract, Phenoxyethanol, Polyaminopropyl Biguanide, Fragrance.

INDICATIONS: For use on dogs and cats only. For the management of kerato-seborrheic conditions. 

DIRECTIONS FOR USE: Shake well before use.

For localized application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the targeted area, massage into the skin until fully penetrated. Do not rinse. Let air dry. Once dry, brush the hair coat again.

For whole body application: Apply on dry hair. Brush the hair coat. Dispense 1 or 2 pumps in the hand and then apply on the skin and hair. Massage into the skin until fully penetrated. Repeat as many times as necessary to cover the whole body, avoiding areas around the eyes and mouth. Do not rinse. Let air dry. Once dry, brush the hair coat 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 can be doubled for long-haired breeds.

Apply every 3 days for 2 to 3 weeks or as recommended by your veterinarian. May be used in protocol with SkinGuard® Balance Shampoo, bathing on day 1 and applying the mousse on day 3 and day 6.

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

WARNING: Keep out of the reach of children.

STORAGE CONDITIONS: Store at room temperature. Do not freeze.

Authorized for sale through licensed veterinarians only.

Distributed by Vicar Operating, Inc.

Los Angeles, CA 90064

Manufactured for Ceva Animal Health, LLC

Lenexa, KS 66215

Questions? Call us at 1-800-999-0297

PRINCIPAL DISPLAY PANEL - 200 mL (6.8 OUNCE) BOTTLE

balance

PHYTOSPHINGOSINE HCl 0.2%

Soap-free mousse helps
restore the skin’s natural
moisture balance and clear
dryness and flakiness

VETHICAL®

SkinGuard®

WITH PHYTOSPHINGOSINE

200 ml (6.8 fl. oz.)

200 mL bottle label

SKINGUARD  BALANCE MOUSSE
phytosphingosine hydrochloride liquid
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:50386-1380
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE2 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
CAPRAMIDOPROPYL BETAINE (UNII: IQ93EE887Z)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
PPG-3 (UNII: 3C8845E7C1)  
GLYCERIN (UNII: PDC6A3C0OX)  
PANTHENOL (UNII: WV9CM0O67Z)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
POLYGLYCERYL-10 LAURATE (UNII: MPJ2Q8WI8G)  
DIPROPYLENE GLYCOL (UNII: E107L85C40)  
BOSWELLIA SERRATA RESIN OIL (UNII: 5T1XCE6K8K)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYAMINOPROPYL BIGUANIDE (UNII: 322U039GMF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50386-1380-1200 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/16/2017
Labeler - Vicar Operating Inc. (052503799)
Registrant - Ceva Sante Animale (261126049)

Revised: 11/2017
Document Id: e0369839-72fc-4f36-ad8d-65ffc57b6de4
Set id: 552bad91-45ea-44ed-885d-71dc1cf7c0c3
Version: 1
Effective Time: 20171116
 
Vicar Operating Inc.