SKINGUARD BALANCE- phytosphingosine hydrochloride shampoo

SkinGuard by

Drug Labeling and Warnings

SkinGuard by is a Animal medication manufactured, distributed, or labeled by Vicar Operating Inc., Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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 & USAGE

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.

WARNINGS AND PRECAUTIONS

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 AND HANDLING

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

Authorized for sale through licensed veterinarians only. 

SPL UNCLASSIFIED SECTION

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)

INGREDIENTS AND APPEARANCE

SKINGUARD  BALANCE
phytosphingosine hydrochloride shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 50386-1390
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	PHYTOSPHINGOSINE HYDROCHLORIDE	1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50386-1390-1	237 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/30/2017

Labeler - Vicar Operating Inc. (052503799)

Registrant - Ceva Sante Animale (261126049)