Label: CERASOOTHE CHX PLUS KET- chlorhexidine gluconate, ketoconazole spray
- NDC Code(s): 11695-6975-1
- 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 2, 2022
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DESCRIPTION
CeraSoothe CHX+KET
Antiseptic Topical Spray
Fragrance: Cucumber melon
A leave-on spray with chlorhexidine and ketoconazole, 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%, 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: Apply 1 to 3 times per day for 2-3 weeks or as directed by your veterinarian. Part the fur and spray directly on the affected area of the skin. Gently smooth product on the skin to ensure full coverage. Wash hands after use. Do not allow the animal to lick the treated area.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle
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INGREDIENTS AND APPEARANCE
CERASOOTHE CHX PLUS KET
chlorhexidine gluconate, ketoconazole sprayProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-6975 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:11695-6975-1 237 mL in 1 BOTTLE, SPRAY 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)