PHYTO P ANTI-ITCH MOUSSE- pramoxine hydrochloride, phytosphingosine salicyloyl liquid

Phyto by

Drug Labeling and Warnings

Phyto by is a Animal medication manufactured, distributed, or labeled by Butler Animal Health Supply, LLC dba Covetrus North America, Ceva Sante Animale. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

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 lbs

Dosage may be doubled for long-haired breeds.

PRECAUTIONS

Cautions: For external use on dogs and cats only. Avoid contact with eyes. If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Wash hands after use.

STORAGE AND HANDLING

Storage: Store at room temperature. Do not freeze.

SPL UNCLASSIFIED SECTION

Questions? (855) 724-3461

Distributed by:
Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com

PRINCIPAL DISPLAY PANEL - 6.8 fl oz (200 mL)

covetrus

NDC: 11695-7233-2

Phyto P 

Pramoxine HCl 1%, 

phytosphingosine salicloyl 0.05%

Anti-itch Mousse

Soothing mousse for dogs and cats

For animal use only

Keep out of reach of children

SHAKE WELL BEFORE USE

Net contents: 6.8 fl oz (200 mL)

INGREDIENTS AND APPEARANCE

PHYTO  P ANTI-ITCH MOUSSE
pramoxine hydrochloride, phytosphingosine salicyloyl liquid

Product 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)