SUFFUSION EAR CLEANER- salicylic acid, phytosphingosine hcl solution

Suffusion by

Drug Labeling and Warnings

Suffusion by is a Animal medication manufactured, distributed, or labeled by Aspen Veterinary Resource, LTD., Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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.

INDICATIONS & USAGE

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.

WARNINGS AND PRECAUTIONS

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 AND HANDLING

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

SPL UNCLASSIFIED SECTION

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)

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)

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)

INGREDIENTS AND APPEARANCE

SUFFUSION  EAR CLEANER
salicylic acid, phytosphingosine hcl solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-168
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)
EDETATE SODIUM (UNII: MP1J8420LU)
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: 46066-168-80	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 46066-168-90	237 mL in 1 BOTTLE, PLASTIC
3	NDC: 46066-168-91	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		09/27/2019

Labeler - Aspen Veterinary Resource, LTD. (627265361)

Registrant - Ceva Sante Animale (261126049)