CeraSoothe by Butler Animal Health Supply, LLC dba Covetrus North America / Ceva Sante Animale

CeraSoothe by

Drug Labeling and Warnings

CeraSoothe 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]

CERASOOTHE SA- salicylic acid shampoo 
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.

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CeraSoothe SA

Antiseborrheic Shampoo

Fragrance: Cucumber melon

For use on cats and dogs

A cleansing and deep conditioning shampoo for follicular flushing. Salicylic acid helps unclog pores to remove excessive scales and crust. 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 ingredient: Salicylic acid 2%.

Inactive ingredients: Water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, PEG-7 glyceryl cocoate, PEG-120 methyl glucose dioleate, sodium chloride, glycerin, sodium lactate, avena sativa (oat) kernal extract, ceramide EOP, ceramide EOS, ceramide NP, carthamus tinctorius (safflower) seed oil, disodium cocamphodiacetate, sodium hydroxide, PEG-8 laurate, laureth-4, fragrance, potassium sorbate, methylchloroisothiazolinone, methylisothiazolinone.

Indications: For use on cats and dogs to help manage dry, flaky, and itchy skin associated with seborrheic sicca.

Direactions for use: Bathe 2 to 3 times per week until symptoms subside or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply shampoo first on the skin abnormalities. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water. Wash hands after use. For a rinse-free solution between baths, use CeraSoothe SA antiseborrheic mousse.

Cautions: For external use on cats and dogs only. Avoid contact with the eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.

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

Antiseborrheic Shampoo

Fragrance: Cucumber melon

Salicylic acid 2%,

For use on cats and dogs

Keep out of reach of children

For animal use only

NDC: 11695-6981-1

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

Antiseborrheic Shampoo

Fragrance: Cucumber melon

Salicylic acid 2%,

For use on cats and dogs

Keep out of reach of children

For animal use only

NDC: 11695-6981-2

Net contents: 16 fl oz (473 mL)

covetrus

16 ounce bottle label

CERASOOTHE  SA
salicylic acid shampoo
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC: 11695-6981
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SALICYLIC ACID (UNII: O414PZ4LPZ) (SALICYLIC ACID - UNII:O414PZ4LPZ) SALICYLIC ACID20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
PEG-7 GLYCERYL COCOATE (UNII: VNX7251543)  
PEG-120 METHYL GLUCOSE DIOLEATE (UNII: YM0K64F20V)  
SODIUM CHLORIDE (UNII: 451W47IQ8X)  
GLYCERIN (UNII: PDC6A3C0OX)  
SODIUM LACTATE (UNII: TU7HW0W0QT)  
AVENANTHRAMIDES (UNII: 5PA41O4AIT)  
CERAMIDE 1 (UNII: 5THT33P7X7)  
CERAMIDE EOS (UNII: CR0J8RN66K)  
CERAMIDE NP (UNII: 4370DF050B)  
SAFFLOWER OIL (UNII: 65UEH262IS)  
DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
PEG-8 LAURATE (UNII: 762O8IWA10)  
LAURETH-4 (UNII: 6HQ855798J)  
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)  
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 11695-6981-1237 mL in 1 BOTTLE, PLASTIC
2NDC: 11695-6981-2473 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other04/30/202108/30/2022
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 8/2022
 
Butler Animal Healt

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