Animal NDC 11695-7222-6 Phyto Ket

Ketoconazole, Phytosphingosine Hydrochloride

Animal Product Information

Field Name Field Value
Animal NDC Code 11695-7222-6
Proprietary Name Phyto Ket 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 Ketoconazole, Phytosphingosine 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 Butler Animal Health Supply, Llc Dba Covetrus North America
Product Type Otc Animal Drug
Usage Information
    Indications: For the antiseptic cleansing of skin and ears.Directions for use: Shake well before use. Skin cleaning: Apply liberally to the affected area(s). Use cotton or absorbent material to clean excess solution and wipe away debris. Do not allow the animal to lick the treated area until dry to prevent ingestion.Ear flushing: Instill liberally into the ear canal while keeping the ear flap up. Gently massage the base of the ear for a few seconds. Wipe the interior flap with cotton or gauze.Apply twice daily or as directed by your veterinarian. Wash hands after use.
Active Ingredient(s)
  • Ketoconazole
  • Phytosphingosine Hydrochloride
Inactive Ingredient(s)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • NONOXYNOL-9 (48Q180SH9T)
  • TROMETHAMINE (023C2WHX2V)
  • EDETATE DISODIUM (7FLD91C86K)
  • METHYLISOTHIAZOLINONE (229D0E1QFA)
  • WATER (059QF0KO0R)
  • ALCOHOL (3K9958V90M)
  • NONOXYNOL-9 (48Q180SH9T)
  • TROMETHAMINE (023C2WHX2V)
  • EDETATE DISODIUM (7FLD91C86K)
  • 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.

Phyto Ket 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



Phyto KET Antiseptic Flush

Active ingredients: Ketoconazole 0.1%, phytosphingosine HCI 0.01%.

Inactive ingredients: Water, SDA 40B 190 proof, nonoxynol-9, disodium EDTA, tromethamine, methylisothiazolinone.

Properties: Phyto KET antiseptic flush is an antiseptic (antibacterial and antifungal) solution for gentle cleansing and flushing of ears and skin. Contains ketoconazole for the management of yeasts and fungi, and preservatives for antibacterial activity. It also contains phytosphingosine, a pro-ceramide to help support a healthy skin barrier. Phytosphingosine HCl also has antiseptic properties.


Indications & Usage



Indications: For the antiseptic cleansing of skin and ears.

Directions for use: Shake well before use. 

Skin cleaning: Apply liberally to the affected area(s). Use cotton or absorbent material to clean excess solution and wipe away debris. Do not allow the animal to lick the treated area until dry to prevent ingestion.

Ear flushing: Instill liberally into the ear canal while keeping the ear flap up. Gently massage the base of the ear for a few seconds. Wipe the interior flap with cotton or gauze.

Apply twice daily or as directed by your veterinarian. Wash hands after use.


Precautions



Cautions: For external use on dogs, cats, and horses 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 in the case of a suspected ruptured eardrum.


Storage And Handling



Storage: Store at room temperature. Do not freeze.


Other



Questions? (855) 724-3461

Distributed by:
Covetrus North America
400 Metro Place North
Dublin, OH 43017
covetrus.com


Principal Display Panel - 4 Ounce (118 Ml) Bottle



covetrus

11695-7222-4

Phyto KET

Ketoconazole 0.1%, 

phytosphingosine HCl 0.01%

Antiseptic Flush

Antiseptic solution for cleansing and flushing of ears and skin for dogs, cats and horses

For animal use only

Keep out of reach of children

Net Contents: 4 fl oz (118 mL)


Principal Display Panel - 16 Ounce (473 Ml) Bottle



covetrus

11695-7222-6

Phyto KET

Ketoconazole 0.1%,

phytosphingosine HCl 0.01%

Antiseptic Flush

Antiseptic solution for cleansing and flushing of ears and skin for dogs, cats and horses

For animal use only

Keep out of reach of children

Net Contents: 16 fl oz (473 mL)


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