SKINGUARD BALANCE- phytosphingosine hydrochloride shampoo 
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.

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SkinGuard® Balance Shampoo

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

ACTIVE INGREDIENT: Phytosphingosine HCl 0.1%.

INACTIVE INGREDIENTS: Water, Cocamidopropyl Betaine, Sodium Laureth Sulfate, Decyl Glucoside, Cyclopentasiloxane, Coco Glucoside, Coconut Alcohol, Acrylates/Steareth-20 Methacrylate Copolymer, Acrylates Copolymer, Triethanolamine, Polyquaternium-10, Phenoxyethanol, Polyperfluoromethylisopropyl Ether, Methylparaben, Fragrance, Polyquaternium-7, Methylchloroisothiazolinone, Methylisothiazolinone.

PROPERTIES:SkinGuard® Balance is a formulation designed to cleanse greasy and/or dry, scaly skin of dogs and cats. It is soap-free and contains moisturizers and film-forming agents to help maintain a normal production of sebum and skin cells. SkinGuard® Balance also contains phytosphingosine, a pro-ceramide to help soothe skin irritations and support a healthy skin barrier.

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

DIRECTIONS FOR USE: Shake well before use. Wet the animal with warm water and apply SkinGuard® Balance. 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 1 to 2 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 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 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 - 8 ounce (237 mL) BOTTLE

balance

Phytosphingosine HCl 0.1%

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

SkinGuard®

VETHICAL®

WITH PHYTOSPINGOSINE

8 FL OZ (237 mL)

8 ounce bottle label - Front

8 ounce bottle label - Back

SKINGUARD  BALANCE
phytosphingosine hydrochloride shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:50386-1390
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
SODIUM LAURETH SULFATE (UNII: BPV390UAP0)  
SODIUM DECYLGLUCOSIDE HYDROXYPROPYLSULFONATE (UNII: B306V77S6R)  
COCO GLUCOSIDE (UNII: ICS790225B)  
COCONUT ALCOHOL (UNII: 13F4MW8Y9K)  
CYCLOMETHICONE 5 (UNII: 0THT5PCI0R)  
STEARETH-20 METHACRYLATE (UNII: A268NZ57NB)  
TROLAMINE (UNII: 9O3K93S3TK)  
PHENOXYETHANOL (UNII: HIE492ZZ3T)  
POLYQUATERNIUM-10 (400 CPS AT 2%) (UNII: HB1401PQFS)  
ETHYL ACRYLATE/METHACRYLIC ACID/STEARETH-20 METHACRYLATE COPOLYMER (UNII: EPA1872R1N)  
PERFLUOROPOLYMETHYLISOPROPYL ETHER (UNII: X6324K3MBW)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYQUATERNIUM-7 (70/30 ACRYLAMIDE/DADMAC; 1600 KD) (UNII: 0L414VCS5Y)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50386-1390-1237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/30/2017
Labeler - Vicar Operating Inc. (052503799)
Registrant - Ceva Sante Animale (261126049)

Revised: 11/2017
Document Id: f59aa0a5-bff0-4b7d-9c33-1e9e39daca42
Set id: 90246442-ddab-48aa-bec5-de4a0a463462
Version: 2
Effective Time: 20171130
 
Vicar Operating Inc.