CERASOOTHE CHX- chlorhexidine gluconate shampoo

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]

DESCRIPTION

CeraSoothe CHX

Antiseptic Shampoo

Fragrance: Fresh and clean

Chlorhexidine gluconate 4%

Formulated for cats, dogs and horses

Keep out of reach of children

For animal use only

A shampoo with chlorhexidine, an antibacterial and antifungal ingredient for antiseptic skin cleansing. 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: Chlorhexidine gluconate 4%

Inactive ingredients: Water, lauramine oxide, cocamidopropyl betaine, polyacrylate-1 crosspolymer, disodium oleamido MIPA sulfosuccinate, decyl glucoside, glycolic acid, avena sativa (oat) kernal extract, glycerin, ceramide EOS, ceramide EOP, ceramide NP, potassium sorbate, fragrance, tetrasodium EDTA, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone, Yellow 6.

INDICATIONS & USAGE

Indications: For use on cats, dogs and horses with bacterial or fungal skin infections responsive to chlorhexidine.

Directions for use: Bathe 2-3 times per week until symptoms subside or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply the shampoo first on the skin abnormalities. Starting with a quarter-size amount of product, massage in 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.

WARNINGS AND PRECAUTIONS

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

STORAGE AND HANDLING

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

SPL UNCLASSIFIED SECTION

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43107

covetrus.com

Questions?

(855) 724-3461

PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle

Inspired by veterinarians

CeraSoothe CHX

Antiseptic Shampoo

Fragrance: Fresh and clean

Chlorhexidine gluconate 4%

Formulated for cats, dogs and horses

Keep out of reach of children

For animal use only

NDC: 11695-6968-1

Net Contents: 8 FL. OZ. (237 mL)

covetrus

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

Inspired by veterinarians

CeraSoothe CHX

Antiseptic Shampoo

Fragrance: Fresh and clean

Chlorhexidine gluconate 4%

Formulated for cats, dogs and horses

Keep out of reach of children

For animal use only

NDC: 11695-6968-2

Net Content: 16 FL. OZ. (473 mL)

covetrus

INGREDIENTS AND APPEARANCE

CERASOOTHE  CHX
chlorhexidine gluconate shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-6968
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	40 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
GLYCOLIC ACID (UNII: 0WT12SX38S)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
GLYCERIN (UNII: PDC6A3C0OX)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
EDETATE SODIUM (UNII: MP1J8420LU)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-6968-1	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-6968-2	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/02/2021

Labeler - BUTLER ANIMAL HEALTH SUPPLY, LLC DBA COVETRUS NORTH AMERICA (603750329)

Registrant - Ceva Sante Animale (261126049)