SKINGUARD BALANCE MOUSSE- phytosphingosine hydrochloride liquid

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 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 & USAGE

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.

WARNINGS AND PRECAUTIONS

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 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 - 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.)

INGREDIENTS AND APPEARANCE

SKINGUARD  BALANCE MOUSSE
phytosphingosine hydrochloride liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 50386-1380
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	PHYTOSPHINGOSINE HYDROCHLORIDE	2 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50386-1380-1	200 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/16/2017

Labeler - Vicar Operating Inc. (052503799)

Registrant - Ceva Sante Animale (261126049)