Label: SUFFUSION P- pramoxine hydrochloride shampoo
- NDC Code(s): 46066-077-90, 46066-077-91
- 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 April 2, 2021
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
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DESCRIPTION
Suffusion™ P
FOR DOGS AND CATS
Pramoxine HCl 1%
ANTI-ITCH
SHAMPOO & CONDITIONER
ACTIVE INGREDIENTS: Pramoxine HCI 1%.
INACTIVE INGREDIENTS: Water, Sodium C14-16 Olefin Sulfonate, PEG-7 Glyceryl Cocoate, Sodium Chloride, Disodium Cocoamphodiacetate, Cocamidopropyl Betaine, Glycerin, Sodium Lactate, Avena Sativa (Oat) Kernal Extract, Ceramide EOP, Ceramide EOS, Ceramide NP, Carthamus Tinctorius (Safflower) Seed Oil, PEG-8, Laurate, Laureth-4, Fragrance, Citric Acid, Potassium Sorbate, Methylchloroisothiazolinone, Methylisothiazolinone.
PROPERTIES: Suffusion™ P Shampoo is a conditioning shampoo with pramoxine to help relieve itching. Skin nourishing nutrients moisturize and calm the skin. They also support the skin's natural immune system and provide building blocks for renewed skin barrier integrity.
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INDICATIONS & USAGE
INDICATIONS: For use on dogs or cats for the temporary relief of itching and skin irritations.
DIRECTIONS FOR USE: Bathe 2-3 times per week until symptoms subside or as directed by your veterinarian. Wet the animal with cool water from the neck down and apply shampoo first on the skin abnormalities. Starting with a quarter-size amount of product, massage into the fur to reach the skin. Repeat until the entire body is lightly coated with shampoo. Leave shampoo on for 10 minutes before rinsing with cool water. Wash hands after use. For a rinse-free solution between baths, use Suffusion™ P Mousse or Suffusion HC Spray.
- WARNINGS AND PRECAUTIONS
- STORAGE AND HANDLING
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL - 8 OUNCE (237 mL) Bottle
- PRINCIPAL DISPLAY PANEL - 16 OUNCE (473 mL) Bottle
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INGREDIENTS AND APPEARANCE
SUFFUSION P
pramoxine hydrochloride shampooProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-077 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 Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) SODIUM C14-16 OLEFIN SULFONATE (UNII: O9W3D3YF5U) PEG-7 GLYCERYL COCOATE (UNII: VNX7251543) SODIUM CHLORIDE (UNII: 451W47IQ8X) DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) GLYCERIN (UNII: PDC6A3C0OX) SODIUM LACTATE (UNII: TU7HW0W0QT) AVENANTHRAMIDES (UNII: 5PA41O4AIT) CERAMIDE 1 (UNII: 5THT33P7X7) CERAMIDE EOS (UNII: CR0J8RN66K) CERAMIDE NP (UNII: 4370DF050B) SAFFLOWER OIL (UNII: 65UEH262IS) PEG-8 LAURATE (UNII: 762O8IWA10) LAURETH-4 (UNII: 6HQ855798J) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) POTASSIUM SORBATE (UNII: 1VPU26JZZ4) METHYLCHLOROISOTHIAZOLINONE (UNII: DEL7T5QRPN) METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46066-077-90 237 mL in 1 BOTTLE, PLASTIC 2 NDC:46066-077-91 473 mL in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 04/02/2021 Labeler - Aspen Veterinary Resource, LTD. (627265361) Registrant - Ceva Sante Animale (261126049)
