CeraSoothe

Manufacturer
Butler Animal Health Supply, LLC dba Covetrus North America | Ceva Sante Animale
Effective date
2025-09-10
Label type
OTC ANIMAL DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 02:44:58

Label at a glance#

ProductCeraSoothe SA Ear Cleaner
Active ingredientSALICYLIC ACID
Label structure7 sections

Storage and handling

Storage:  Store at room temperature. Do not freeze.

Label contents#

Full prescribing information#

DESCRIPTION SECTION

CeraSoothe SA

Otic Cleansing Solution

Fragrance: Cucumber melon

Formulated for cats, dogs, and horses

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. Ceramides and avenanthramides are skin nourishing nutrients that moisturize and calm the skin. They also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.

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.

INDICATIONS & USAGE SECTION

Indications: For use on cats, dogs, and horses 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 excess solution with a clean cotton ball. Wask hands after use.

WARNINGS AND PRECAUTIONS SECTION

Cautions: For external use on cats, dogs, and horses only. Avoid contact with the 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.

STORAGE AND HANDLING SECTION

Storage: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

Questions?

(855) 724-3461

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Inspired by veterinarians

CeraSoothe™
SA

Otic Cleansing Solution
Fragrance: Cucumber melon

Salicylic acid 0.15%

Formulated for cats, dogs, and horses

Keep out of reach of children
For animal use only

NDC: 11695-6989-1
Net contents: 8 fl oz (237mL)

covetrus

PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 237 mL Bottle Label

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Inspired by veterinarians

CeraSoothe™
SA

Otic Cleansing Solution
Fragrance: Cucumber melon

Salicylic acid 0.15%

Formulated for cats, dogs, and horses

Keep out of reach of children
For animal use only

NDC: 11695-6989-2
Net contents: 16 fl oz (473mL)

covetrus

PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 473 mL Bottle Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2541052salicylic acid 0.15 % Otic SolutionPSN3
2541052salicylic acid 1.5 MG/ML Otic SolutionSCD3
2541052salicylic acid 0.15 % Otic SolutionSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11695-6989-1CeraSootheSA Ear Cleaner237 mL in 1 BOTTLE, PLASTICSOLUTION2373
11695-6989-2CeraSootheSA Ear Cleaner473 mL in 1 BOTTLE, PLASTICSOLUTION4733

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
11695-698911695-6989-1, 11695-6989-2

Ingredients#

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

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

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.