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 Patterson Veterinary, 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 is specifically formulated to deodorize and gently clean, dry and acidify the ear canal. This provides an optimal environment to help maintain healthy ears. Suffusion Ear Cleaner also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.

INDICATIONS & USAGE

INDICATION: 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 the 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.

SPL UNCLASSIFIED SECTION

QUESTIONS? 1-800-999-0297

Distributed by:
Patterson Veterinary
822 7th Street, Suite 740
Greeley, CO 80631
www.pattersonvet.com

PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle

NDC: 14043-027-04

PATTERSON® VETERINARY

Suffusion

Ear Cleaner

Salicylic Acid 0.15%,

Phytosphingosine HCl 0.01%

Cleansing/Drying Solution

dogs  cats

Phytosphingosine

Net Content: 4 FL. OZ. (118 mL)

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

NDC: 14043-027-08

PATTERSON® VETERINARY

Suffusion

Ear Cleaner

Salicylic Acid 0.15%,

Phytosphingosine HCl 0.01%

Cleansing/Drying Solution

dogs cats

Phytosphingosine

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

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

NDC: 14043-027-16

PATTERSON® VETERINARY

Suffusion

Ear Cleaner

Salicylic Acid 0.15%,

Phytosphingosine HCl 0.01%

Cleansing/Drying Solution

dogs cats

Phytosphingosine

Net Content: 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: 14043-027
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: 14043-027-04	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 14043-027-08	237 mL in 1 BOTTLE, PLASTIC
3	NDC: 14043-027-16	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/01/2017

Labeler - Patterson Veterinary (006962500)

Registrant - Ceva Sante Animale (261126049)