CERASOOTHE CHX PLUS MC MOUSSE- chlorhexidine gluconate, miconazole liquid

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+MC

Antiseptic Mousse

Formulated for cats, dogs, and horses

A leave-on mousse with chlorhexidine and miconazole, antibacterial and antifungal ingredients for antiseptic activity on the skin. 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, SD alcohol 40-B, propylene glycol, propylene glycol laurate, polysorbate 80, benzyl alcohol, poloxamer 184, cocamidopropyl betaine, avena sativa (oat) kernel extract, ceramide EOP, ceramide EOS, ceramide NP, glycerin, potasssium sorbate.

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.Brush the fur and then apply on dry hair. Apply every 3 days for 2-3 weeks or as directed by your veterinarian. Wash hands after use.

For localized application: Dispense 1 - 2 pumps onto your palm and then apply on the targeted area(s). Massage into the skin until fully penetrated. Do not rinse, let air dry. Once dry, brush the fur again.

For whole body application: Dispense 1 or 2 pumps onto your palm and then apply on the skin and hair. Massage into the skin until fully penetrated. Repeat as necessary to cover the whole body, avoiding the eyes and mouth. Do not rinse, let air dry. Once dry, brush the fur again.

Dosage:
Under 11 lbs: 1 pump per 2 lbs
11-88 lbs: 1 pump per 4 lbs
Over 88 lbs: 1 pump per 6 lbs
Dosage may be doubled for long-haired dogs.

For deeper cleansing, use CeraSoothe CHX+MC antiseptic shampoo.

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 - 5 OUNCE (148 mL) Bottle

Inspired by veterinarians

CeraSoothe CHX+MC

Antiseptic Mousse

Chlorhexidine Gluconate 2%, Miconazole 2%

Formulated for cats, dogs, and horses

Keep out of reach of children

For animal use only

NDC: 11695-6977-1

Net contents: 5 fl oz (148 mL)

covetrus

INGREDIENTS AND APPEARANCE

CERASOOTHE  CHX PLUS MC MOUSSE
chlorhexidine gluconate, miconazole liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-6977
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)
ALCOHOL (UNII: 3K9958V90M)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
PROPYLENE GLYCOL LAURATES (UNII: 40KT317HGP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
BENZYL ALCOHOL (UNII: LKG8494WBH)
POLOXAMER 184 (UNII: BIS92ZSF57)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
AVENANTHRAMIDES (UNII: 5PA41O4AIT)
CERAMIDE 1 (UNII: 5THT33P7X7)
CERAMIDE EOS (UNII: CR0J8RN66K)
CERAMIDE NP (UNII: 4370DF050B)
GLYCERIN (UNII: PDC6A3C0OX)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11695-6977-1	148 mL in 1 BOTTLE, PUMP

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/21/2021

Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)

Registrant - Ceva Sante Animale (261126049)