Label: PHYTO CHX KET ANTISEPTIC- chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl shampoo
- NDC Code(s): 11695-7225-1, 11695-7225-6, 11695-7225-8
- 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 November 14, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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DESCRIPTION
Phyto CHX+KET Antiseptic Shampoo
Active Ingredrients: Chlorhexidine gluconate 2%, ketoconazole 1%, phytosphingosine salicyloyl 0.05%.
Inactive Ingredients: Water, lauramine oxide, cocamidopropyl betaine, polyacrylate-1 crosspolymer, decyl glucoside, glycolic acid, fragrance, tetrasodium EDTA, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone.
Properties: Phyto CHX+KET antiseptic shampoo is formulated with chlorhexidine gluconate and ketoconazole, antibacterial and antifungal agents for skin cleansing. This low-lather formula contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.
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INDICATIONS & USAGE
Indications: For use on dogs, cats, and horses only. For the management of bacterial and fungal skin infections responsive to chlorhexidine gluconate and ketoconazole.
Directions for use: Use 2 to 3 times per week until symptoms subside or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply shampoo first on the areas with skin abnormalities. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water. For a rinse-free solution between baths, ask your veterinarian about Phyto CHX+KET spray or mousse.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle
- PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle
- PRINCIPAL DISPLAY PANEL - 1 Gallon Jug
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INGREDIENTS AND APPEARANCE
PHYTO CHX KET ANTISEPTIC
chlorhexidine gluconate, ketoconazole, phytosphingosine salicyloyl shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-7225 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 SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) PHYTOSPHINGOSINE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) GLYCOLIC ACID (UNII: 0WT12SX38S) SODIUM CHLORIDE (UNII: 451W47IQ8X) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) EDETATE SODIUM (UNII: MP1J8420LU) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-7225-8 237 mL in 1 BOTTLE, PLASTIC 2 NDC:11695-7225-6 473 mL in 1 BOTTLE, PLASTIC 3 NDC:11695-7225-1 3785 mL in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2020 Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329) Registrant - Ceva Sante Animale (261126049)
