Animal NDC 86166-111-04 Mysimplepetlab Infected Ear Relief

Ketoconazole

Animal Product Information

Field Name Field Value
Animal NDC Code 86166-111-04
Proprietary Name Mysimplepetlab Infected Ear Relief 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 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 Mysimplepetlab Inc
Product Type Otc Animal Drug
Usage Information
    • shake well before use • apply liberally to the affected area(s) • apply twice daily or as directed by veterinarian • 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 • wash hands after use.
Active Ingredient(s)
  • Ketoconazole
Inactive Ingredient(s)
  • BENZYL ALCOHOL (LKG8494WBH)
  • EDETATE DISODIUM ANHYDROUS (8NLQ36F6MM)
  • NONOXYNOL-9 (48Q180SH9T)
  • ALCOHOL (3K9958V90M)
  • TROMETHAMINE (023C2WHX2V)
  • WATER (059QF0KO0R)
  • BENZYL ALCOHOL (LKG8494WBH)
  • EDETATE DISODIUM ANHYDROUS (8NLQ36F6MM)
  • NONOXYNOL-9 (48Q180SH9T)
  • ALCOHOL (3K9958V90M)
  • TROMETHAMINE (023C2WHX2V)
  • WATER (059QF0KO0R)
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.

Mysimplepetlab Infected Ear Relief Images

Mysimplepetlab Infected Ear Relief 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



Drug Facts




Active Ingredient



Ketoconazole 0.1%


Purpose



Antifungal


Uses



• antiseptic (antifungal) solution for gentle cleansing and flushing of ears and skin • contains ketoconazole for the management of fungal activity.


Warnings



For animal use only.

For topical use only. Avoid contact with eyes or mucous membranes. In case of contact, flush eyes with water and seek medical attention if undue irritation persists.

Consult your veterinarian and discontinue use if undue skin irritation develops or increases.

Keep out of the reach of children.


Directions



• shake well before use • apply liberally to the affected area(s) • apply twice daily or as directed by veterinarian • 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 • wash hands after use.


Other Information



Store at controlled room temperature.


Inactive Ingredients



Benzyl Alcohol, Disodium EDTA, Fragrance, Nonoxynol-9, SD Alcohol 40-B, Tromethamine, Water.


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