Suffusion SA Ear Cleaner: Product Information

SUFFUSION SA EAR CLEANER- salicylic acid 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.

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: 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.

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 CONDITIONS: Store at room temperature. Do not freeze.

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)

4 oz bottle label
(click image for full-size original)

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)

8 ounce bottle label
(click image for full-size original)

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)

16 ounce bottle
(click image for full-size original)
SUFFUSION SA EAR CLEANER
salicylic acid solution
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-078
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SALICYLIC ACID (SALICYLIC ACID) SALICYLIC ACID 1.5 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
ALCOHOL
PROPYLENE GLYCOL
GLYCERIN
BENZOIC ACID
BENZYL ALCOHOL
DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE
NONOXYNOL-12
DOCUSATE SODIUM
LACTIC ACID
ALOE VERA LEAF
AVENANTHRAMIDES
CERAMIDE 1
CERAMIDE EOS
CERAMIDE NP
POTASSIUM SORBATE
EDETATE SODIUM
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46066-078-88 118 mL in 1 BOTTLE, PLASTIC None
2 NDC:46066-078-90 237 mL in 1 BOTTLE, PLASTIC None
3 NDC:46066-078-91 473 mL in 1 BOTTLE, PLASTIC None
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)

Revised: 05/2021 Aspen Veterinary Resource, LTD.

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