PHYTO P CREME- pramoxine hydrochloride, phytosphingosine salicyloyl rinse 
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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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.

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.

Cautions: For external use on dogs, cats, and horses 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 - 8 fl oz (237 mL)

covetrus

NDC 11695-7231-8

Phyto P

Pramoxine HCl 1%,

phytosphingosine salicyloyl 0.05%

Anti-itch Créme Rinse

Soothing conditioner for dogs, cats and horses

For animal use only

Keep out of reach of children

Net contents: 8 fl oz (237 mL)

8 ounce bottle

PHYTO  P CREME
pramoxine hydrochloride, phytosphingosine salicyloyl rinse
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:11695-7231
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11695-7231-8237 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: 6a51de7e-13a5-4704-ab08-4b1f2e4fec47
Set id: ce818dbf-7e23-421b-b52d-25d94d3148c5
Version: 1
Effective Time: 20191205
 
Butler Animal Health Supply, LLC dba Covetrus North America