Label: SUFFUSION SA EAR CLEANER- salicylic acid solution
- NDC Code(s): 46066-078-88, 46066-078-90, 46066-078-91
- Packager: Aspen Veterinary Resource, LTD.
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated May 4, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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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.
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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.
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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
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle
- PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle
- PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle
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INGREDIENTS AND APPEARANCE
SUFFUSION SA EAR CLEANER
salicylic acid solutionProduct 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)
