FDA.reportPublic FDA data

Suffusion

Manufacturer
Aspen Veterinary Resource, LTD. | Ceva Sante Animale
Effective date
2021-05-04
Label type
OTC ANIMAL DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:40:58

Label at a glance#

ProductSuffusion SA Ear Cleaner
Active ingredientSALICYLIC ACID
Label structure8 sections

Storage and handling

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

Label contents#

Full prescribing information#

DESCRIPTION SECTION

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 SECTION

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 SECTION

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 SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 label4 oz bottle label

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 label8 ounce bottle label

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 bottle16 ounce bottle

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2541052salicylic acid 0.15 % Otic SolutionPSN1
2541052salicylic acid 1.5 MG/ML Otic SolutionSCD1
2541052salicylic acid 0.15 % Otic SolutionSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46066-078-88SuffusionSA Ear Cleaner118 mL in 1 BOTTLE, PLASTICSOLUTION1181
46066-078-90SuffusionSA Ear Cleaner237 mL in 1 BOTTLE, PLASTICSOLUTION2371
46066-078-91SuffusionSA Ear Cleaner473 mL in 1 BOTTLE, PLASTICSOLUTION4731

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46066-078SUFFUSION SA EAR CLEANER (SALICYLIC ACID) SOLUTION [ASPEN VETERINARY RESOURCE, LTD.]13 package rows20210505_fe859882-4c93-4ead-bb3d-b2b9649aba07.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
46066-07846066-078-88, 46066-078-90, 46066-078-91

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
GLYCERINPDC6A3C0OXIACT
BENZOIC ACID8SKN0B0MIMIACT
BENZYL ALCOHOLLKG8494WBHIACT
DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE0MBZ20845FIACT
NONOXYNOL-126NR43D77O6IACT
DOCUSATE SODIUMF05Q2T2JA0IACT
LACTIC ACID33X04XA5ATIACT
ALOE VERA LEAFZY81Z83H0XIACT
AVENANTHRAMIDES5PA41O4AITIACT
CERAMIDE 15THT33P7X7IACT
CERAMIDE EOSCR0J8RN66KIACT
CERAMIDE NP4370DF050BIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
EDETATE SODIUMMP1J8420LUIACT
SALICYLIC ACIDO414PZ4LPZACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsName fallback
generic name: WATER
NINA WATER (Rich anions,Alkaline Balancing Water)WATERDMBIO.CO.,LTD.58cbda7e-70c9-af85-e063-6394a90a0d172026-08-11WarningsName fallback
generic name: WATER
NINA WATER (Rich anions,Alkaline Balancing Water)WATERDMBIO.CO.,LTD.58b9b24c-7014-eb45-e063-6294a90ae4822026-08-10WarningsName fallback
generic name: WATER
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsName fallback
generic name: WATER
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsName fallback
generic name: WATER
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsName fallback
generic name: WATER
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsName fallback
generic name: WATER
NINA WATER (Rich anions)WATERBIOHERB Co., Ltd.16053e79-189e-4cdf-e063-6394a90ac7762026-04-11WarningsName fallback
generic name: WATER
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsName fallback
generic name: WATER
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsName fallback
generic name: WATER
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsName fallback
generic name: WATER
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsName fallback
generic name: WATER
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsName fallback
generic name: WATER
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsName fallback
generic name: WATER
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsName fallback
generic name: WATER
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsName fallback
generic name: WATER

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.