Label: PHYTO EFA- phytosphingosine salicyloyl shampoo
- NDC Code(s): 11695-7230-1, 11695-7230-6, 11695-7230-8
- 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 December 17, 2019
If you are a consumer or patient please visit this version.
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DESCRIPTION
Phyto EFA Moisturizing Shampoo
Active ingredients: Phytosphingosine salicyloyl 0.02%.
Inactive ingredients: Water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, sodium chloride, sodium lactate, fragrance, glycerin, disodium cocoamphodiacetate, propylene glycol, hydroxypropyl methylcellulose, citric acid, tetrasodium EDTA, carthamus tinctorius (safflower) seed oil, methylchloroisothiazolinone, methylisothiazolinone.
Properties: Phyto EFA moisturizing shampoo is for grooming and moisturizing dry or sensitive skin. Emollients and fatty acids hydrate and soothe the skin and help control dryness and irritations. This low-lather shampoo also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier.
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INDICATIONS & USAGE
Indications: For the management of dry, irritated, or sensitive skin.
Directions for use: Bathe as needed or as directed by your veterinarian. Wet the animal with lukewarm water from the neck down and apply shampoo. 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. Rinse with lukewarm water. For a rinse-free treatment between baths, ask your veterinarian about Phyto EFA moisturizing mousse.
- PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 fl oz (237 mL)
- PRINCIPAL DISPLAY PANEL - 16 fl oz (473 mL)
- PRINCIPAL DISPLAY PANEL - 1 GALLON (3.785 L)
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INGREDIENTS AND APPEARANCE
PHYTO EFA
phytosphingosine salicyloyl shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-7230 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE 0.2 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) SODIUM LACTATE (UNII: TU7HW0W0QT) GLYCERIN (UNII: PDC6A3C0OX) PROPYLENE GLYCOL (UNII: 6DC9Q167V3) HYPROMELLOSES (UNII: 3NXW29V3WO) EDETATE DISODIUM (UNII: 7FLD91C86K) SAFFLOWER OIL (UNII: 65UEH262IS) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-7230-8 237 mL in 1 BOTTLE, PLASTIC 2 NDC:11695-7230-6 473 mL in 1 BOTTLE, PLASTIC 3 NDC:11695-7230-1 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)
