Suffusion P MOUSSE: Product Information

SUFFUSION P MOUSSE- pramoxine hydrochloride 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.

Suffusion™ P

FOR DOGS & CATS

ANTI-ITCH MOUSSE

ACTIVE INGREDIENTS: Pramoxine HCl 1%.

INACTIVE INGREDIENTS: Water, Glycerin, PEG-8 Dimethicone, Polysorbate 80, Poloxamer 184, Sodium Lactate, Aloe Barbadensis (Aloe) Leaf Juice, Avena Sativa (Oat) Kernel Extract, Ceramide EOP, Ceramide EOS, Ceramide NP, Fragrance, Potassium Sorbate, Methylisothiazolinone.

PROPERTIES: Suffusion™ P Mousse is a leave-on mousse with pramoxine to help relieve itching. Skin nourishing nutrients moisturize and calm the skin. The also support the skin’s natural immune system and provide building blocks for renewed skin barrier integrity.

INDICATIONS: For use on dogs or cats for the temporary relief of itching and skin irritations.

DIRECTIONS FOR USE: Brush the fur and then apply on dry hair. Apply every 3 days for 2 to 3 weeks or as directed by your veterinarian. Wash hands after use.

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 into the skin until fully penetrated. Repeat 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

12-88 lbs: 1 pump per 4 lbs

Over 88 lbs: 1 pump per 6 lbs

Dosage may be doubled for long-haired dogs. For deeper cleansing, use Suffusion P Anti-Itch Conditioning Shampoo.

CAUTIONS: For external use on dogs and cats only. Avoid contact with eyes. In case of contact with eyes, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian.

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

Pivetal

NDC 46066-073-15

SUFFUSION™ P

FOR DOGS & CATS

Pramoxine HCl 1%

ANTI-ITCH MOUSSE

TEMPORARY ITCHING RELIEF

6.8 fl oz (200 mL)

200 mL bottle label
(click image for full-size original)
SUFFUSION P MOUSSE
pramoxine hydrochloride liquid
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-073
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
PRAMOXINE HYDROCHLORIDE (PRAMOXINE) PRAMOXINE HYDROCHLORIDE 10 mg in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
PEG-8 DIMETHICONE
POLYSORBATE 80
POLOXAMER 184
ALOE VERA LEAF
AVENANTHRAMIDES
CERAMIDE 1
CERAMIDE EOS
CERAMIDE NP
POTASSIUM SORBATE
METHYLISOTHIAZOLINONE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:46066-073-15 200 mL in 1 BOTTLE, PLASTIC None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/22/2021
Labeler — Aspen Veterinary Resource, LTD. (627265361)
Registrant — Ceva Sante Animale (261126049)

Revised: 04/2021 Aspen Veterinary Resource, LTD.

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