SKINGUARD CLEANSE RINSE- salicylic acid, phytosphingosine hydrochloride solution 
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.

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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: 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.

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 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 - 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)

8 ounce bottle label

SKINGUARD  CLEANSE RINSE
salicylic acid, phytosphingosine hydrochloride solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:50386-1400
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.5 mg  in 1 mL
PHYTOSPHINGOSINE HYDROCHLORIDE (UNII: TT871XV7TU) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE HYDROCHLORIDE0.1 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50386-1400-1237 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other11/28/2017
Labeler - Vicar Operating Inc (052503799)
Registrant - Ceva Sante Animale (261126049)

Revised: 4/2021
Document Id: 4808e309-410b-463d-a2d9-027a10e275e8
Set id: e07327b5-743b-44d6-8abc-f4a74d6524ba
Version: 3
Effective Time: 20210426
 
Vicar Operating Inc