SKINGUARD CLEANSE RINSE- salicylic acid, phytosphingosine hydrochloride solution

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® Cleanse Rinse

Medicated rinse gently cleans ears

CUCUMBER/MELON SCENT

ACTIVE INGREDIENTS: Salicylic Acid 0.15%, Phytosphingosine HCl 0.01%.

INACTIVE INGREDIENTS: Water, SDA 40B 190 Proof, Propylene Glycol, Disodium Oleamido MIPA Sulfosuccinate, Nonoxynol-12, Glycerin, Fragrance, Benzoic Acid, Benzyl Alcohol, Lactic Acid, Tetrasodium EDTA, Sodium Dioctyl Sulfosuccinate, Aloe Barbadensis Leaf Juice.

PROPERTIES: SkinGuard® Cleanse is specifically formulated to deodorize and gently clean, dry and acidify the ear canal. This provides an optimal environment to help maintain healthy ears. SkinGuard® Cleanse also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS & USAGE

INDICATIONS: For use on dogs and cats only. For cleansing and/or drying the ear canal.

DIRECTIONS FOR USE: Apply liberally into the ear canal. Massage the base of the ear. Allow pet to shake head. Clean excess with a cotton ball. In excessively dirty ears, apply 2-3 times daily over several days. For maintenance of healthy ears, apply 1-2 times weekly or as directed by your veterinarian. Recommended after swimming to help dry ear canal.

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. Do not use in the case of a suspected ruptured eardrum.

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

cleanse

SALICYLIC ACID 0.15%, PHYTOSPHINGOSINE HCl 0.01%

Medicated rinse gently

cleans ears

CUCUMBER/MELON SCENT

VETHICAL®

SkinGuard®

WITH PHYTOSPHINGOSINE

Net Content: 8 FL. OZ. (237 mL)

INGREDIENTS AND APPEARANCE

SKINGUARD  CLEANSE RINSE
salicylic acid, phytosphingosine hydrochloride solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 50386-1400
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ)	SALICYLIC ACID	1.5 mg  in 1 mL
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q)	PHYTOSPHINGOSINE HYDROCHLORIDE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F)
NONOXYNOL-12 (UNII: 6NR43D77O6)
GLYCERIN (UNII: PDC6A3C0OX)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
LACTIC ACID (UNII: 33X04XA5AT)
DITETRACYCLINE TETRASODIUM EDETATE (UNII: WX0A0IT7K5)
DI-N-OCTYL SODIUM SULFOSUCCINATE (UNII: 4YLY5570Y0)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 50386-1400-1	237 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/28/2017

Labeler - Vicar Operating Inc (052503799)

Registrant - Ceva Sante Animale (261126049)