Label: CERASOOTHE CK MOUSSE- chlorhexidine gluconate, ketoconazole liquid
- NDC Code(s): 11695-6974-1
- Packager: Butler Animal Health Supply, LLC dba Covetrus North America
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated May 5, 2022
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DESCRIPTION
CeraSoothe CHX+KET
Antiseptic Mousse
Fragrance: Cucumber melon
A leave-on mousse with chlorhexidine and ketoconazole, antibacterial and antifungal ingredients for antiseptic activity on 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%, ketoconazole 1%.
Inactive ingredients: Water, glycerin, polysorbate 20, propylene glycol, lactic acid, avena sativa (oat) kernal extract, ceramide EOP, ceramide EOS, ceramide NP, fragrance, potassium sorbate, methylisothiazolinone.
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INDICATIONS & USAGE
Indications: For use on cats, dogs and horses with bacterial or fungal skin infections that are responsive to chlorhexidine or ketoconazole.
Directions for use: Brush the fur and then apply on dry hair. Apply every 3 days for 2 to 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 many times and 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 breeds. For deeper cleansing, use Ceraven CHX+KET antiseptic shampoo.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6.8 OUNCE (200 mL) Bottle
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INGREDIENTS AND APPEARANCE
CERASOOTHE CK MOUSSE
chlorhexidine gluconate, ketoconazole liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-6974 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 KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE 10 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) GLYCERIN (UNII: PDC6A3C0OX) POLYSORBATE 20 (UNII: 7T1F30V5YH) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) LACTIC ACID (UNII: 33X04XA5AT) AVENANTHRAMIDES (UNII: 5PA41O4AIT) CERAMIDE 1 (UNII: 5THT33P7X7) CERAMIDE EOS (UNII: CR0J8RN66K) CERAMIDE NP (UNII: 4370DF050B) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-6974-1 200 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/16/2021 Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329) Registrant - Ceva Sante Animale (261126049)
