Animal NDC 46066-077-90 Suffusion P

Pramoxine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 46066-077-90
Proprietary Name Suffusion P What is the Proprietary Name?
The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name Pramoxine Hydrochloride What is the Non-Proprietary Name?
The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name Aspen Veterinary Resource, Ltd.
Product Type Otc Animal Drug
Usage Information
    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.
Active Ingredient(s)
  • Pramoxine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (O9W3D3YF5U)
  • PEG-7 GLYCERYL COCOATE (VNX7251543)
  • SODIUM CHLORIDE (451W47IQ8X)
  • DISODIUM COCOAMPHODIACETATE (18L9G3U51M)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • GLYCERIN (PDC6A3C0OX)
  • SODIUM LACTATE (TU7HW0W0QT)
  • AVENANTHRAMIDES (5PA41O4AIT)
  • CERAMIDE 1 (5THT33P7X7)
  • CERAMIDE EOS (CR0J8RN66K)
  • CERAMIDE NP (4370DF050B)
  • SAFFLOWER OIL (65UEH262IS)
  • PEG-8 LAURATE (762O8IWA10)
  • LAURETH-4 (6HQ855798J)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • WATER (059QF0KO0R)
  • SODIUM C14-16 OLEFIN SULFONATE (O9W3D3YF5U)
  • PEG-7 GLYCERYL COCOATE (VNX7251543)
  • SODIUM CHLORIDE (451W47IQ8X)
  • DISODIUM COCOAMPHODIACETATE (18L9G3U51M)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • GLYCERIN (PDC6A3C0OX)
  • SODIUM LACTATE (TU7HW0W0QT)
  • AVENANTHRAMIDES (5PA41O4AIT)
  • CERAMIDE 1 (5THT33P7X7)
  • CERAMIDE EOS (CR0J8RN66K)
  • CERAMIDE NP (4370DF050B)
  • SAFFLOWER OIL (65UEH262IS)
  • PEG-8 LAURATE (762O8IWA10)
  • LAURETH-4 (6HQ855798J)
  • CITRIC ACID MONOHYDRATE (2968PHW8QP)
  • POTASSIUM SORBATE (1VPU26JZZ4)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
Marketing Category UNAPPROVED DRUG OTHER What is the Marketing Category?
Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.

Suffusion P Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Table of Contents



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.


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



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 And Handling



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


Other



QUESTIONS? 1-800-999-0297

Pivetal

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


Principal Display Panel - 8 Ounce (237 Ml) Bottle



Pivetal

NDC 46066-077-90

SUFFUSION™ P

FOR CATS & DOGS

Pramoxine HCl 1%

ANTI-ITCH

SHAMPOO & CONDITIONER

8 fl oz (237 mL)


Principal Display Panel - 16 Ounce (473 Ml) Bottle



Pivetal

NDC 46066-077-91

SUFFUSION™ P

FOR CATS & DOGS

Pramoxine HCl 1%

ANTI-ITCH

SHAMPOO & CONDITIONER

16 fl oz (473 mL)


* The information on this page is for an ANIMAL PRODUCT, please review the complete disclaimer below.