SKINGUARD RELIEVE MOUSSE- pramoxine hydrochloride, phytosphingosine salicyloyl 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® 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 & USAGE

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.

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 - 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)

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056)	PRAMOXINE HYDROCHLORIDE	10 mg  in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH)	SALICYLOYL PHYTOSPHINGOSINE	0.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
PEG-8 DIMETHICONE (UNII: GIA7T764OD)
SODIUM LACTATE (UNII: TU7HW0W0QT)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
POLOXAMER 184 (UNII: BIS92ZSF57)
OAT (UNII: Z6J799EAJK)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50386-1420-1	200 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/04/2017

Labeler - Vicar Operating Inc (052503799)

Registrant - Ceva Sante Animale (261126049)