Label: PHYTO P ANTI-ITCH MOUSSE- pramoxine hydrochloride, phytosphingosine salicyloyl liquid
- NDC Code(s): 11695-7233-2
- 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
If you are a consumer or patient please visit this version.
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DESCRIPTION
Phyto P Anti-itch Mousse
Active Ingredients: Pramoxine HCl 1%, phytosphingosine salicloyl 0.05%.
Inactive ingredients: Water, glycerin, PEG-8 dimethicone, polysorbate 80, poloxamer 184, sodium lactate, hydrolyzed oat protein, fragrance, aloe barbadensis leaf extract, methylisothiazolinone.
Properties: Phyto P anti-itch mousse is formulated for the temporary relief of itching in dogs and cats without bathing. It contains pramoxine HCl, a mild numbing agent, as well as colloidal oatmeal and aloe vera to soothe irritated skin. This no-rinse mousse also contains phytosphingosine, a pro-ceramide, to 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. Brush the fur then apply product on dry hair. Apply every 3 days for 2-3 weeks or as directed by your veterinarian.
For localized application: Dispense 1-2 pumps onto your palm, then apply on the targeted area(s). Massage into the skin until fully penetrated. Do not rinse, let air dry. Once dry, brush the fur again.
For whole body application: Dispense 1 to 2 pumps onto your palm and massage onto the skin. Repeat as many times as necessary to cover the whole body, avoiding the eyes and mouth. Do not rinse, let air dry. Once dry, brush the fur again.
Dosage:
Under 11 lbs: 1 pump per 2 lbs
11 - 88 lbs: 1 pump per 4 lbs
Over 88 lbs: 1 pump per 6 lbsDosage may be doubled for long-haired breeds.
- PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6.8 fl oz (200 mL)
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INGREDIENTS AND APPEARANCE
PHYTO P ANTI-ITCH MOUSSE
pramoxine hydrochloride, phytosphingosine salicyloyl liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:11695-7233 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) GLYCERIN (UNII: PDC6A3C0OX) PEG-8 DIMETHICONE (UNII: GIA7T764OD) SODIUM LACTATE (UNII: TU7HW0W0QT) POLYSORBATE 80 (UNII: 6OZP39ZG8H) POLOXAMER 184 (UNII: BIS92ZSF57) OAT (UNII: Z6J799EAJK) ALOE VERA LEAF (UNII: ZY81Z83H0X) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:11695-7233-2 200 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)
