CERASOOTHE CHX PLUS MC- chlorhexidine gluconate, miconazole nitrate shampoo

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 CHX+MC

Antiseptic Shampoo

Fragrance: Cucumber melon

Formulated for cats, dogs, and horses

A shampoo with chlorhexidine and miconazole, antibacterial and antifungal ingredients for 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 ingredients: Chlorhexidine gluconate 2%, miconazole nitrate 2%.

Inactive ingredients: Water, lauramine oxide, cocamidopropyl betaine, decyl glucoside, polyacrylate-1 crosspolymer, lactic acid, acetic acid, avena sativa (oat) kernel extract, glycerin, ceramide EOP, ceramide EOS, ceramide NP, fragrance, potassium sorbate, sodium hydroxide, methylchloroisothiazolinone, methylisothiazoline.

INDICATIONS & USAGE

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

Directions for use: Shake well before 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 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 CHX+MC antiseptic mousse and/or wipes.

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 with your veterinarian.

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 CHX+MC

Antiseptic Shampoo

Fragrance: Cucumber melon

Chlorhexidine gluconate 2%

Miconazole nitrate 2%

Formulated for cats, dogs, and horses

Keep out of reach of children

For animal use only

NDC: 11695-6980-1

Net contents: 8 fl oz (237 mL)

PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle

Inspired by veterinarians

CeraSoothe CHX+MC

Antiseptic Shampoo

Fragrance: Cucumber melon

Chlorhexidine gluconate 2%

Miconazole nitrate 2%

Formulated for cats, dogs, and horses

Keep out of reach of children

For animal use only

NDC: 11695-6980-2

Net contents: 16 fl oz (473 mL)

INGREDIENTS AND APPEARANCE

CERASOOTHE  CHX PLUS MC
chlorhexidine gluconate, miconazole nitrate shampoo

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-6980
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)
LACTIC ACID (UNII: 33X04XA5AT)
ACETIC ACID (UNII: Q40Q9N063P)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
GLYCERIN (UNII: PDC6A3C0OX)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-6980-1	237 mL in 1 BOTTLE, PLASTIC
2	NDC: 11695-6980-2	473 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		04/09/2021

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

Registrant - Ceva Sante Animale (261126049)