Label: SUFFUSION P PS MOUSSE- pramoxine hydrochloride, phytosphingosine salicyloyl liquid
- NDC Code(s): 46066-165-14
- Packager: Aspen Veterinary Resource, LTD.
- 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 October 10, 2019
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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DESCRIPTION
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.
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INDICATIONS & USAGE
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.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 6.8 OUNCE (200 mL) Bottle
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INGREDIENTS AND APPEARANCE
SUFFUSION P PS MOUSSE
pramoxine hydrochloride, phytosphingosine salicyloyl liquidProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-165 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:46066-165-14 200 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/11/2019 Labeler - Aspen Veterinary Resource, LTD. (627265361) Registrant - Ceva Sante Animale (261126049)
