Label: CERASOOTHE KET- ketoconazole solution
- NDC Code(s): 11695-6979-1, 11695-6979-2
- 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 23, 2022
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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DESCRIPTION
CeraSoothe KET
Antiseptic Flush
Fragrance free
Ketoconazole 0.1%
Formulated for cats and dogs
Keep out of reach of children
For animal use only
A gentle antifungal and antibacterial skin and ear cleansing solution. Ketoconazole fights yeast and fungi. Tromethamine (TRIS) helps break down bacteria cell walls. 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: Ketoconazole 0.1%.
Inactive ingredients: Water, SD Alcohol 40-B, nonoxynol-9, disodium EDTA, tromethamine, avena sativa (oat) kernal extract, glycerin, ceramide EOP, ceramide EOS, ceramide NP, potassium sorbate, methylisothiazolinone.
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INDICATIONS & USAGE
Indications: For use on cats and dogs for the antiseptic cleansing of skin and ears.
Directions for use: Apply twice a day or as directed by your veterinarian. Wash hands after use.
Ear cleaning: Moisten a cotton ball with solution and place in entrance of ear canal, or hold the ear flap upwards and fill the ear canal with solution. Then, gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away debris and excess solution with a clean, dry cotton ball.
Skin cleaning: Moisten absorbent material with solution and gently wipe the area to clean and remove debris. Repeat as necessary until clean.
- PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 4 OUNCE (118 mL) Bottle
- PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle
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INGREDIENTS AND APPEARANCE
CERASOOTHE KET
ketoconazole solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-6979 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength KETOCONAZOLE (UNII: R9400W927I) (KETOCONAZOLE - UNII:R9400W927I) KETOCONAZOLE 1 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) ALCOHOL (UNII: 3K9958V90M) NONOXYNOL-9 (UNII: 48Q180SH9T) EDETATE DISODIUM (UNII: 7FLD91C86K) TROMETHAMINE (UNII: 023C2WHX2V) AVENANTHRAMIDES (UNII: 5PA41O4AIT) GLYCERIN (UNII: PDC6A3C0OX) 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:11695-6979-1 118 mL in 1 BOTTLE, PLASTIC 2 NDC:11695-6979-2 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/02/2021 Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329) Registrant - Ceva Sante Animale (261126049)
