Animal NDC 46066-342-90 Pivetal Suffusion M Antiseptic

Chlorhexidine Gluconate, Miconazole Nitrate

Animal Product Information

Field Name Field Value
Animal NDC Code 46066-342-90
Proprietary Name Pivetal Suffusion M Antiseptic 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 Chlorhexidine Gluconate, Miconazole Nitrate 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 Resources, Ltd.
Product Type Otc Animal Drug
Usage Information
    For use on dogs or cats with bacterial or fungal skin infections that are responsive to chlorhexidine or miconazole.
Active Ingredient(s)
  • Chlorhexidine Gluconate
  • Miconazole Nitrate
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • LAURAMINE OXIDE (4F6FC4MI8W)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • MYRISTAMINE OXIDE (J086PM3RRT)
  • DECYL GLUCOSIDE (Z17H97EA6Y)
  • POLYACRYLATE-1 CROSSPOLYMER (R5P9Z5WD6D)
  • LACTIC ACID, UNSPECIFIED FORM (33X04XA5AT)
  • ACETIC ACID (Q40Q9N063P)
  • DECYLAMINE OXIDE (G387VUT5EZ)
  • PALMITAMINE OXIDE (9DJ9RBA18Z)
  • SODIUM CHLORIDE (451W47IQ8X)
  • GLYCERIN (PDC6A3C0OX)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • OAT (Z6J799EAJK)
  • CERAMIDE NP (4370DF050B)
  • CERAMIDE AP (F1X8L2B00J)
  • CERAMIDE 9 (88KCS7120E)
  • PHYTOSPHINGOSINE (GIN46U9Q2Q)
  • WATER (059QF0KO0R)
  • LAURAMINE OXIDE (4F6FC4MI8W)
  • COCAMIDOPROPYL BETAINE (5OCF3O11KX)
  • MYRISTAMINE OXIDE (J086PM3RRT)
  • DECYL GLUCOSIDE (Z17H97EA6Y)
  • POLYACRYLATE-1 CROSSPOLYMER (R5P9Z5WD6D)
  • LACTIC ACID, UNSPECIFIED FORM (33X04XA5AT)
  • ACETIC ACID (Q40Q9N063P)
  • DECYLAMINE OXIDE (G387VUT5EZ)
  • PALMITAMINE OXIDE (9DJ9RBA18Z)
  • SODIUM CHLORIDE (451W47IQ8X)
  • GLYCERIN (PDC6A3C0OX)
  • METHYLCHLOROISOTHIAZOLINONE (DEL7T5QRPN)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • OAT (Z6J799EAJK)
  • CERAMIDE NP (4370DF050B)
  • CERAMIDE AP (F1X8L2B00J)
  • CERAMIDE 9 (88KCS7120E)
  • PHYTOSPHINGOSINE (GIN46U9Q2Q)
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.

Pivetal Suffusion M Antiseptic Images

Pivetal Suffusion M Antiseptic 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



Active Ingredients:



Chlorhexidine Gluconate 2%, Miconazole Nitrate 2%.


Inactive Ingredients:



Water, Lauramine Oxide, Cocamidopropyl Betaine, N,N Dimethyltetradecylamine Oxide, Decyl Glucoside, Polyacrylate-1 Crosspolymer, Lactic Acid, Acetic Acid, Decylamine Oxide, Cetamine Oxide, Fragrance, Sodium Chloride, Glycerin, Methylchloroisothiazolinone, Methylisothiazolinone, Avena Sativa (Oat) Kernel Extract, Ceramide NP, Ceramide AP, Ceramide EOP, Phytosphingosine.


Properties:



Suffusion™ M Shampoo is a shampoo with chlorhexidine and miconazole, antibacterial and antifungal ingredients for antiseptic skin cleansing. 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:



For use on dogs or cats with bacterial or fungal skin infections that are responsive to chlorhexidine or miconazole.


Directions For Use:



Shake well before 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™ M Mousse or Suffusion™ M Wipes.

WET ANIMAL WITH COOL WATER

TREAT ABNORMALITIES FIRST

LEAVE SHAMPOO 10 MINUTES THEN RINSE

USE 2-3 TIMES PER WEEK


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?



[email protected]


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