CERASOOTHE CHX PLUS MC WIPES- chlorhexidine gluconate, miconazole nitrate swab

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 Wipes

Formulated for cats, dogs and horses

Antiseptic wipes 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 dogs, cats, and horses with bacterial or fungal skin infections that are responsive to chlorhexidine or miconazole.

Directions for use: Wipe the targeted area 1 to 3 times daily, or use as directed by your veterinarian. Do not allow the animal to lick the treated area. Do not reuse wipes. Wash hands after use.

WARNINGS AND PRECAUTIONS

Cautions:  For external use on dogs, cats, 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

Distributed by:

Covetrus North America

400 Metro Place North

Dublin, OH 43017

covetrus.com

Questions? (855)724-3461

PRINCIPAL DISPLAY PANEL - 30 wipe canister

Inspired by veterinarians

CeraSoothe CHX+MC

Antiseptic Wipes

Fragrance free

Chlorhexidine gluconate 2%, miconazole nitrate 2%

Formulated for cats, dogs, and horses

Keep out of reach of children

For animal use only

Net contents: 30 wipes

covetrus

INGREDIENTS AND APPEARANCE

CERASOOTHE  CHX PLUS MC WIPES
chlorhexidine gluconate, miconazole nitrate swab

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 11695-6978
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
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg

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: 11695-6978-1	30 in 1 CANISTER

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)