Animal NDC 46066-168-90 Suffusion Ear Cleaner
Salicylic Acid, Phytosphingosine Hcl

Animal Product Information

Field Name Field Value
Animal NDC Code 46066-168-90
Proprietary Name Suffusion Ear Cleaner 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 Salicylic Acid, Phytosphingosine Hcl 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
    INDICATION: For cleansing and/or drying the ear canal in dogs and cats.DIRECTIONS FOR USE: Ask your veterinarian which of the two following protocols is best for your pet:1) Moisten a cotton ball with solution and place at the entrance of the ear canal; OR2) Hold ear flap upward and fill with solution.Then gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away visible debris and exceess solution with a clean cotton ball.
Active Ingredient(s)
  • Salicylic Acid
  • Phytosphingosine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (0MBZ20845F)
  • NONOXYNOL-12 (6NR43D77O6)
  • GLYCERIN (PDC6A3C0OX)
  • BENZOIC ACID (8SKN0B0MIM)
  • BENZYL ALCOHOL (LKG8494WBH)
  • LACTIC ACID (33X04XA5AT)
  • EDETATE SODIUM (MP1J8420LU)
  • DI-N-OCTYL SODIUM SULFOSUCCINATE (4YLY5570Y0)
  • ALOE VERA LEAF (ZY81Z83H0X)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • PROPYLENE GLYCOL (6DC9Q167V3)
  • DISODIUM OLEAMIDO MIPA-SULFOSUCCINATE (0MBZ20845F)
  • NONOXYNOL-12 (6NR43D77O6)
  • GLYCERIN (PDC6A3C0OX)
  • BENZOIC ACID (8SKN0B0MIM)
  • BENZYL ALCOHOL (LKG8494WBH)
  • LACTIC ACID (33X04XA5AT)
  • EDETATE SODIUM (MP1J8420LU)
  • DI-N-OCTYL SODIUM SULFOSUCCINATE (4YLY5570Y0)
  • ALOE VERA LEAF (ZY81Z83H0X)
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 Ear Cleaner 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 Ear Cleaner

ACTIVE INGREDIENTS: Salicylic Acid 0.15%, Phytosphingosine HCl 0.01%.

INACTIVE INGREDIENTS: Water, SDA 40B 190 Proof, Propylene Glycol, Disodium Oleamido MIPA Sulfosuccinate, Glycerin, Nonoxynol-12, Benzoic Acid, Benzyl Alcohol, Lactic Acid, Tetrasodium EDTA, Sodium Dioctyl Sulfosuccinate, Aloe Barbadensis Leaf Juice, Fragrance.

PROPERTIES: Suffusion Ear Cleaner gently cleans, deodorizes and dries the ear canal to help maintain healthy ears. It contains aloe vera to moisturize, and phytosphingosine, a pro-ceramide, to help support a healthy skin barrier.


Indications & Usage



INDICATION: For cleansing and/or drying the ear canal in dogs and cats.

DIRECTIONS FOR USE: Ask your veterinarian which of the two following protocols is best for your pet:

1) Moisten a cotton ball with solution and place at the entrance of the ear canal; OR

2) Hold ear flap upward and fill with solution.

Then gently massage the base of the ear for 60 seconds. Remove cotton ball (if used) and allow pet to shake its head. Gently wipe away visible debris and exceess solution with a clean cotton ball.


Warnings And Precautions



CAUTIONS: For external use on dogs and cats only. Avoid contact with the eyes.  If eye contact occurs, rinse thoroughly and consult your veterinarian. If skin irritation occurs or increases, discontinue use and consult with your veterinarian. Do not use with a suspected ruptured eardrum. Wash hands after use.

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 - 4 Ounce (118 Ml) Bottle



NDC 46066-168-80

SUFFUSION™

Ear Cleaner

Salicylic Acid 0.15%,

Phytosphingosine HCl 0.01%

Cleansing/Drying Solution

FOR CATS & DOGS

Phytosphingosine

Wellness

• PIVETAL •

4 FL. OZ. (118 mL)


Principal Display Panel - 8 Ounce (237 Ml) Bottle



NDC 46066-168-90

SUFFUSION™

Ear Cleaner

Salicylic Acid 0.15%,

Phytosphingosine HCl 0.01%

Cleansing/Drying Solution

FOR CATS & DOGS

Phytosphingosine

Wellness

• PIVETAL •

8 FL. OZ. (237 mL)


Principal Display Panel - 16 Ounce (473 Ml) Bottle



NDC 46066-168-91

SUFFUSION™

Ear Cleaner

Salicylic Acid 0.15%,

Phytosphingosine HCl 0.01%

Cleansing/Drying Solution

FOR CATS & DOGS

Phytosphingosine

Wellness

• PIVETAL •

16 FL. OZ. (473 mL)


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