SUFFUSION SA EAR CLEANER- salicylic acid 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™ SA

FOR DOGS & CATS

EAR CLEANER

ACTIVE INGREDIENTS: Salicylic Acid 0.15%.

INACTIVE INGREDIENTS: Water, SD Alcohol 40-B, Propylene Glycol, Glycerin, Benzoic Acid, Benzyl Alcohol, Disodium Oleamido MIPA Sulfosuccinate, Nonoxynol-12, Diethylhexyl Sodium Sulfosuccinate, Lactic Acid, Aloe Barbadensis (Aloe Vera) Leaf Juice, Avena Sative (Oat) Kernel Oil, Ceramide EOP, Ceramide EOS, Ceramide NP, Fragrance, Potassium Sorbate, Tetrasodium EDTA.

PROPERTIES: Suffusion™ SA Ear Cleaner cleans, dries, and deodorizes the ear canal. Contains salicylic acid, a beta-hydroxy acid (BHA) to exfoliate and penetrate dead skin cells, wax build-up and dirt. Skin nourishing nutrients moisturize and calm the skin. They also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.

INDICATIONS & USAGE

INDICATIONS: For use on dogs or cats to cleanse, deodorize and dry the ear canal.

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. Wash hands after use.

WARNINGS AND PRECAUTIONS

CAUTIONS: For external use on dogs and cats only. Avoid contact with 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. 

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

pivetalvet.com

PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle

Pivetal®

NDC: 46066-078-88

Suffusion™ SA

FOR DOGS & CATS

Salicylic Acid 0.15%,

EAR CLEANER

SOOTHES

DRIES

DEODORIZES

4 fl oz (118 mL)

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

Pivetal®

NDC: 46066-078-90

Suffusion™ SA

FOR DOGS & CATS

Salicylic Acid 0.15%,

EAR CLEANER

SOOTHES

DRIES

DEODORIZES

8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

Pivetal®

NDC: 46066-078-91

Suffusion™ SA

FOR DOGS & CATS

Salicylic Acid 0.15%,

EAR CLEANER

SOOTHES

DRIES

DEODORIZES

16 fl oz (473 mL)

INGREDIENTS AND APPEARANCE

SUFFUSION  SA EAR CLEANER
salicylic acid solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-078
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

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
GLYCERIN (UNII: PDC6A3C0OX)
BENZOIC ACID (UNII: 8SKN0B0MIM)
BENZYL ALCOHOL (UNII: LKG8494WBH)
DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F)
NONOXYNOL-12 (UNII: 6NR43D77O6)
DOCUSATE SODIUM (UNII: F05Q2T2JA0)
LACTIC ACID (UNII: 33X04XA5AT)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE SODIUM (UNII: MP1J8420LU)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-078-88	118 mL in 1 BOTTLE, PLASTIC
2	NDC: 46066-078-90	237 mL in 1 BOTTLE, PLASTIC
3	NDC: 46066-078-91	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/30/2021

Labeler - Aspen Veterinary Resource, LTD. (627265361)

Registrant - Ceva Sante Animale (261126049)