CERASOOTHE SA EAR CLEANER- salicylic acid solution 
Butler Animal Health Supply, LLC dba Covetrus North America

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.

----------

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: 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.

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: Store at room temperature. Do not freeze.

Questions?

(855) 724-3461

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

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 (237 mL)

covetrus

8 ounce bottle label

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

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 (473 mL)

covetrus

16 ounce bottle

CERASOOTHE  SA EAR CLEANER
salicylic acid solution
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-6989
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID1.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-6989-1237 mL in 1 BOTTLE, PLASTIC
2NDC:11695-6989-2473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/30/2021
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 6/2022
Document Id: 58023380-5217-4318-a981-251e38743eb2
Set id: 6be18b8d-d3fc-423f-8282-6817497642e4
Version: 2
Effective Time: 20220608
 
Butler Animal Health Supply, LLC dba Covetrus North America