Label: PHYTO P ANTI-ITCH- pramoxine hydrochloride, phytosphingosine salicyloyl shampoo
- NDC Code(s): 11695-7224-1, 11695-7224-6, 11695-7224-8
- 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 4, 2019
If you are a consumer or patient please visit this version.
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DESCRIPTION
Phyto P Anti-itch Shampoo
Active Ingredients: Pramoxine HCI 1%, phytosphingosine salicyloyl 0.05%.
Inactive Ingredients: water, sodium C14-16 olefin sulfonate, cocamidopropyl betaine, disodium cocoamphodiacetate, glycerin, sodium lactate, hydroxypropyl methylcellulose, tetrasodium EDTA, fragrance, hydrolyzed oat protein, carthamus tinctorius (safflower) seed oil, citric acid, sodium chloride, methylchloroisothiazolinone, methylisothiazolinone.
Properties: Phyto P anti-itch shampoo is formulated for the temporary relief of itching in dogs, cats, and horses. This low-lather formula contains pramoxine, a mild numbing agent, as well as colloidal oatmeal and essential fatty acids to soothe irritated skin. It also contains phytosphingosine, a pro-ceramide to help moisturize and support a healthy skin barrier.
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INDICATIONS & USAGE
Indications: For the temporary relief of itching and skin irritations.
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 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. Follow bath with Phyto P anti-itch créme rinse. For a rinse-free solution between baths, ask your veterinarian about Phyto P spray or 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 (3.875 L)
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INGREDIENTS AND APPEARANCE
PHYTO P ANTI-ITCH
pramoxine hydrochloride, phytosphingosine salicyloyl shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-7224 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (PHYTOSPHINGOSINE - UNII:GIN46U9Q2Q) SALICYLOYL PHYTOSPHINGOSINE 0.5 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) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LACTATE (UNII: TU7HW0W0QT) HYPROMELLOSES (UNII: 3NXW29V3WO) EDETATE SODIUM (UNII: MP1J8420LU) SODIUM CHLORIDE (UNII: 451W47IQ8X) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) OATMEAL (UNII: 8PI54V663Y) SAFFLOWER OIL (UNII: 65UEH262IS) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-7224-8 237 mL in 1 BOTTLE, PLASTIC 2 NDC:11695-7224-6 473 mL in 1 BOTTLE, PLASTIC 3 NDC:11695-7224-1 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)
