SkinGuard Relieve Mousse: Product Information

SKINGUARD RELIEVE MOUSSE- pramoxine hydrochloride and salicyloyl phytosphingosine 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® Relieve Mousse

Soap-free mousse that calms irritated skin and relieves itchiness

ACTIVE INGREDIENT: Pramoxine HCl 1%, Phytosphingosine Salicyloyl 0.05%.

INACTIVE INGREDIENTS: Water, Glycerin, PEG-8 Dimethicone, Polysorbate 80, Poloxamer 184, Sodium Lactate, Hydrolyzed Oat Protein, Fragrance, Aloe Barbadensis (Aloe) Leaf Extract, Methylisothiazolinone.

PROPERTIES: SkinGuard® Relieve is a formulation designed for the temporary relief of itching in dogs and cats without bathing. It is soap-free, alcohol-free and moisturizing. SkinGuard® Relieve also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS: For use on dogs and cats only. For the temporary relief of pruritus and skin irritations.

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 may 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. 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 — 6.8 OUNCE (200 mL) Bottle

relieve

PRAMOXINE HCl 1%,

PHYTOSPHINGOSINE SALICYLOYL 0.05%

Soap-free mousse that
calms irritated skin and
relieves itchiness

Vethical®

SkinGuard®

WITH PHYTOSPHINGOSINE

6.8 FL OZ (200 mL)

200 mL bottle label
(click image for full-size original)
SKINGUARD RELIEVE MOUSSE
pramoxine hydrochloride, phytosphingosine salicyloyl liquid
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:50386-1420
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (SALICYLOYL PHYTOSPHINGOSINE) SALICYLOYL PHYTOSPHINGOSINE 0.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PEG-8 DIMETHICONE
SODIUM LACTATE
POLYSORBATE 80
POLOXAMER 184
OAT
ALOE VERA LEAF
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:50386-1420-1 200 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 12/04/2017
Labeler — Vicar Operating Inc (052503799)
Registrant — Ceva Sante Animale (261126049)

Revised: 12/2017 Vicar Operating Inc

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