CERASOOTHE SA EAR CLEANER- salicylic acid solution

Ceraven by

Drug Labeling and Warnings

Ceraven by is a Animal medication manufactured, distributed, or labeled by Butler Animal Health Supply, LLC dba Covetrus North America, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

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

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

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

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 - 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

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

INGREDIENTS AND APPEARANCE

CERASOOTHE  SA EAR CLEANER
salicylic acid solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-6989
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: 11695-6989-1	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-6989-2	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 - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)

Registrant - Ceva Sante Animale (261126049)