SKINGUARD RESTORE- chlorhexidine gluconate, climbazole, phytosphingosine salicyloyl 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® Restore Shampoo

ACTIVE INGREDIENTS: Chlorhexidine Gluconate 3%, Climbazole 0.5%, Phytosphingosine Salicyloyl 0.05%.

INACTIVE INGREDIENTS: Water, Cocamidopropyl Hydroxysultaine, Decyl Glucoside, Capryloyl Glycine, PEG-120 Methyl Glucose Dioleate, Propylene Glycol, Triethanolamine, Phenoxyethanol, Sodium Hydroxide, Fragrance, Citric Acid.

PROPERTIES:SkinGuard® Restore is a formulation designed for the antiseptic cleansing of the skin of dogs and cats. It is soap-free and contains mild cleansing bases and moisturizers. SkinGuard® Restore 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 skin infections that are responsive to chlorhexidine and climbazole.

DIRECTIONS FOR USE: Wet the animal with warm water and apply SkinGuard® Restore. 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

Restore

CHLORHEXIDINE GLUCONATE 3%, CLIMBAZOLE 0.5%,
PHYTOSPHINGOSINE SALICYLOYL 0.05%

Soap-free shampoo with
anti-bacterial and anti-fungal
properties

VETHICAL

SkinGuard®

WITH PHYTOSPHINGOSINE

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

SKINGUARD  RESTORE
chlorhexidine gluconate, climbazole, phytosphingosine salicyloyl shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 50386-1370
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	30 mg  in 1 mL
CLIMBAZOLE (UNII: 9N42CW7I54) (CLIMBAZOLE - UNII:9N42CW7I54)	CLIMBAZOLE	5 mg  in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	SALICYLOYL PHYTOSPHINGOSINE	.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
COCAMIDOPROPYL HYDROXYSULTAINE (UNII: 62V75NI93W)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
CAPRYLOYL GLYCINE (UNII: 8TY5YO42NJ)
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
TROLAMINE (UNII: 9O3K93S3TK)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50386-1370-1	237 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/20/2017

Labeler - Vicar Operating Inc. (052503799)

Registrant - Ceva Sante Animale (261126049)