SkinGuard Restore Mousse: Product Information

SKINGUARD RESTORE MOUSSE- chlorhexidine gluconate, salicyloyl phytosphingosine and climbazole 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® Restore Mousse

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

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

INACTIVE INGREDIENTS: Water, Polysorbate 80, Propylene Glycol, Benzyl Alcohol, Laureth-23, Poloxamer 184, Fragrance.

INDICATIONS: For use on dogs and cats only. For the management of skin infections that are responsive to chlorhexidine and climbazole.

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 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. 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 BOTTLE LABEL

restore

CHLORHEXIDINE GLUCONATE 3%

CLIMBAZOLE 0.5%

PHYTOSPHINGOSINE SALICYLOYL 0.05%

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

VETHICAL®

SkinGuard®

WITH PHYTOSPHINGOSINE

6.8 FL OZ (200 mL)

200 mL bottle label
(click image for full-size original)
SKINGUARD RESTORE MOUSSE
chlorhexidine gluconate, climbazole, phytosphingosine salicyloyl liquid
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50386-1350
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 30 mg in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (PHYTOSPHINGOSINE) SALICYLOYL PHYTOSPHINGOSINE 0.5 mg in 1 mL
CLIMBAZOLE (CLIMBAZOLE) CLIMBAZOLE 5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
POLYSORBATE 80
PROPYLENE GLYCOL
BENZYL ALCOHOL
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50386-1350-1 200 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/06/2017
Labeler — Vicar Operating Inc. (052503799)
Registrant — Ceva Sante Animale (261126049)

Revised: 12/2017 Vicar Operating Inc.

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