Label: SUFFUSION 4% PS- chlorhexidine gluconate, phytosphingosine salicyloyl shampoo
- NDC Code(s): 46066-159-90, 46066-159-91
- Packager: Aspen Veterinary Resource, Ltd.
- 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 September 20, 2019
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DESCRIPTION
Suffusion 4% +PS SHAMPOO
ACTIVE INGREDIENTS: Chlorhexidine Gluconate 4%, Phytosphingosine Salicyloyl 0.05%.
INACTIVE INGREDIENTS: Water, Lauramine Oxide, Cocamidopropyl Betaine, Polyacrylate-1 Crosspolymer, Disodium Oleamido MIPA Sulfosuccinate, Decyl Glucoside, Glycolic Acid, Tetrasodium EDTA, Fragrance, Methylchloroisothiazolinone, Methylisothiazolinone, FD&C Yellow #6.
PROPERTIES: Suffusion 4% +PS Shampoo is formulated with chlorhexidine gluconate, an antibacterial and antifungal agent 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 the management of bacterial or fungal skin infections in dogs and cats that are responsive to chlorhexidine gluconate.
DIRECTIONS FOR USE: Use 2-3 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 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 the shampoo on for 10 minutes before rinsing with cool water until the water runs clear.
- 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
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INGREDIENTS AND APPEARANCE
SUFFUSION 4% PS
chlorhexidine gluconate, phytosphingosine salicyloyl shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-159 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 40 mg in 1 mL SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (UNII: 0MBZ20845F) DECYL GLUCOSIDE (UNII: Z17H97EA6Y) GLYCOLIC ACID (UNII: 0WT12SX38S) EDETATE SODIUM (UNII: MP1J8420LU) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46066-159-90 237 mL in 1 BOTTLE, PLASTIC 2 NDC:46066-159-91 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/27/2019 Labeler - Aspen Veterinary Resource, Ltd. (627265361) Registrant - Ceva Sante Animale (261126049)
