SUFFUSION P PS MOUSSE- pramoxine hydrochloride, phytosphingosine salicyloyl liquid 
Aspen Veterinary Resource, LTD.

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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Pramosoothe +PS 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 (Aloe) Leaf Extract, Methylisothiazolinone.

PROPERTIES: Pramosoothe +PS Mousse is designed for the temporary relief of itching without rinsing. It contains praamoxine, 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 pruritus and skin irritations in dogs and cats. 

DIRECTIONS FOR USE: Shake well before use. Brush the fur and then apply on dry hair. Apply every 3 days for 2-3 weeks or as directed by your veterinarian.

For localized application:Dispense 1 or 2 pumps onto your palm and 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 or 2 pumps onto your palm and then apply on the skin and hair. Massage gently into the skin until fully penetrated. Repeat as many times as necessary to cover the whole body, avoiding areas around 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

12-88 lbs: 1 pump per 4 lbs

Over 88 lbs: 1 pump per 6 lbs

Dosage may be doubled for long-haired dogs.

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.

WARNING: Keep out of reach of children.

STORAGE CONDITIONS: Store at room temperature. Do not freeze.

QUESTIONS? 1-800-999-0297

Pivetal

Distributed by:
Aspen Veterinary Resources , LTD.
Liberty, MO 64068
www.pivetalvet.com

PRINCIPAL DISPLAY PANEL - 6.8 OUNCE (200 mL) Bottle

NDC 46066-165-14

SUFFUSION™

P +PS Mousse

Pramoxine HCl 1%, Phytosphingosine Salicloyl 0.05%

Soothing Mousse

FOR CATS & DOGS

Phytosphingosine

Wellness

• BY PIVETAL •

SHAKE WELL BEFORE USE

6.8 FL. OZ. (200 mL)

200 mL bottle label

SUFFUSION  P PS MOUSSE
pramoxine hydrochloride, phytosphingosine salicyloyl liquid
Product Information
Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-165
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:46066-165-14200 mL in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other10/11/2019
Labeler - Aspen Veterinary Resource, LTD. (627265361)
Registrant - Ceva Sante Animale (261126049)

Revised: 10/2019
Document Id: f989ef37-3b14-42c8-aa91-6607b01f0d3e
Set id: 783942e9-36be-465b-b239-ff5f1eae8af4
Version: 1
Effective Time: 20191010
 
Aspen Veterinary Resource, LTD.