Label: PHYTO P CREME- pramoxine hydrochloride, phytosphingosine salicyloyl rinse
- NDC Code(s): 11695-7231-8
- 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 5, 2019
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DESCRIPTION
PHYTOVET P CRÉME RINSE
Active Ingredients: Pramoxine HCl 1%, phytosphingosine salicyloyl 0.05%.
Inactive ingredients: Water, cetearyl alcohol, PEG-40 hydrogenated castor oil, stearalkonium chloride, polysorbate-60, glycerin, dimethicone, fragrance, hydrolyzed oat protein, hydrolyzed wheat protein, methylchloroisothiazolinone, methylisothiazolinone.
Properties: Phyto P anti-itch créme rinse is formulated for the temporary relief of itching in dogs, cats, and horses. It contains pramoxine, a mild numbing agent, as well as colloidal oatmeal to soothe irritated skin. It also contains phytosphingosine, a pro-ceramide, to moisturize and help support a healthy skin barrier.
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INDICATIONS & USAGE
Indications: For the temporary relief of itching and skin irritations.
Directions for use: Shake well before use. Use 2-3 times per week until symptoms subside or as directed by your veterinarian. After bathing with Phyto P shampoo, apply this product. Starting with the skin abormalities, massage a quarter-size amount of Phyto P créme rinse into the fur to reach the skin. Repeat until entire body is lightly coated. Leave on for 10 minutes before rinsing with cool water. For a rinse-free solution between baths, ask your veterinarian about Phyto P spray or mousse.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 fl oz (237 mL)
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INGREDIENTS AND APPEARANCE
PHYTO P CREME
pramoxine hydrochloride, phytosphingosine salicyloyl rinseProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-7231 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) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE 0.5 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S) PEG-40 CASTOR OIL (UNII: 4ERD2076EF) STEARALKONIUM CHLORIDE (UNII: 0OUO26BB88) POLYSORBATE 60 (UNII: CAL22UVI4M) GLYCERIN (UNII: PDC6A3C0OX) DIMETHICONE (UNII: 92RU3N3Y1O) OATMEAL (UNII: 8PI54V663Y) HYDROLYZED WHEAT PROTEIN (ENZYMATIC, 3000 MW) (UNII: J2S07SB0YL) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-7231-8 237 mL in 1 BOTTLE, PLASTIC 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)
