SUFFUSION EAR CLEANER- salicylic acid, phytosphingosine hcl solution 
Aspen Veterinary Resource, LTD.

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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SUFFUSION Ear Cleaner

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

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

PROPERTIES: Suffusion Ear Cleaner gently cleans, deodorizes and dries the ear canal to help maintain healthy ears. It contains aloe vera to moisturize, and phytosphingosine, a pro-ceramide, to help support a healthy skin barrier.

INDICATION: For cleansing and/or drying the ear canal in dogs and cats.

DIRECTIONS FOR USE: Ask your veterinarian which of the two following protocols is best for your pet:

1) Moisten a cotton ball with solution and place at the entrance of the ear canal; OR

2) Hold ear flap upward and fill with solution.

Then gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away visible debris and exceess solution with a clean cotton ball.

CAUTIONS: For external use on dogs and cats only. Avoid contact with the eyes.  If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Do not use with a suspected ruptured eardrum. Wash hands after use.

WARNING: Keep out of reach of children.

STORAGE CONDITIONS: Store at room temperature. Do not freeze.

QUESTIONS? 1-800-999-0297

Pivetal

Distributed by:

Aspen Veterinary Resources®, LTD.

Liberty, MO 64068

www.pivetalvet.com

PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle

NDC 46066-168-80

SUFFUSION™

Ear Cleaner

Salicylic Acid 0.15%,

Phytosphingosine HCl 0.01%

Cleansing/Drying Solution

FOR CATS & DOGS

Phytosphingosine

Wellness

• PIVETAL •

4 FL. OZ. (118 mL)

4 oz bottle label

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

NDC 46066-168-90

SUFFUSION™

Ear Cleaner

Salicylic Acid 0.15%,

Phytosphingosine HCl 0.01%

Cleansing/Drying Solution

FOR CATS & DOGS

Phytosphingosine

Wellness

• PIVETAL •

8 FL. OZ. (237 mL)

8 ounce bottle label

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

NDC 46066-168-91

SUFFUSION™

Ear Cleaner

Salicylic Acid 0.15%,

Phytosphingosine HCl 0.01%

Cleansing/Drying Solution

FOR CATS & DOGS

Phytosphingosine

Wellness

• PIVETAL •

16 FL. OZ. (473 mL)

16 ounce bottle

SUFFUSION  EAR CLEANER
salicylic acid, phytosphingosine hcl solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-168
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)  
EDETATE SODIUM (UNII: MP1J8420LU)  
DI-N-OCTYL SODIUM SULFOSUCCINATE (UNII: 4YLY5570Y0)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:46066-168-80118 mL in 1 BOTTLE, PLASTIC
2NDC:46066-168-90237 mL in 1 BOTTLE, PLASTIC
3NDC:46066-168-91473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/27/2019
Labeler - Aspen Veterinary Resource, LTD. (627265361)
Registrant - Ceva Sante Animale (261126049)

Revised: 2/2020
Document Id: 9551a818-cc6c-4d24-b04c-16461eb313c8
Set id: c4dcaf3f-fc4f-4b7d-a59f-8f944cea0fa7
Version: 2
Effective Time: 20200225
 
Aspen Veterinary Resource, LTD.