PHYTO P ANTI-ITCH MOUSSE- pramoxine hydrochloride, phytosphingosine salicyloyl liquid 
Butler Animal Health Supply, LLC dba Covetrus North America

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.

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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: 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.

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: Store at room temperature. Do not freeze.

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)

200 mL bottle

PHYTO  P ANTI-ITCH MOUSSE
pramoxine hydrochloride, phytosphingosine salicyloyl liquid
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7233
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
PRAMOXINE HYDROCHLORIDE (UNII: 88AYB867L5) (PRAMOXINE - UNII:068X84E056) PRAMOXINE HYDROCHLORIDE10 mg  in 1 mL
SALICYLOYL PHYTOSPHINGOSINE (UNII: U891J4JCNH) (SALICYLOYL PHYTOSPHINGOSINE - UNII:U891J4JCNH) SALICYLOYL PHYTOSPHINGOSINE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-7233-2200 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/01/2020
Labeler - Butler Animal Health Supply, LLC dba Covetrus North America (603750329)
Registrant - Ceva Sante Animale (261126049)

Revised: 12/2019
Document Id: 4ca3213b-9f25-4c5b-8be8-172a3c72d116
Set id: 472d8d84-ece1-47e1-ad2e-473c80cdd3f4
Version: 1
Effective Time: 20191205
 
Butler Animal Health Supply, LLC dba Covetrus North America