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Animal NDC 54771-1100-2 Kopertox

Copper Naphthenate

Animal Product Information

Field Name Field Value
Animal NDC Code 54771-1100-2
Proprietary Name Kopertox 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 Copper Naphthenate 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 Zoetis
Product Type Otc Animal Drug
Usage Information
    (copper naphthenate)WATER-RESISTANT PROTECTION WITHOUT BANDAGINGRECOMMENDED as an aid in treating horses and ponies with thrush due to organisms susceptible to copper naphthenate. Indicated in the treatment of thrush in horses and ponies
Active Ingredient(s)
  • Copper Naphthenate
Marketing Category ANADA - ABBREVIATED NEW ANIMAL DRUG APPLICATION 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.
FDA Application Number ANADA200304 What is the FDA Application Number?
This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Kopertox Images

Kopertox 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



Indications & Usage



(copper naphthenate)

WATER-RESISTANT PROTECTION WITHOUT BANDAGING

RECOMMENDED as an aid in treating horses and ponies with thrush due to organisms susceptible to copper naphthenate.

Indicated in the treatment of thrush in horses and ponies


Precautions



Do not use in horses intented for human consumption.

CAUTION:  COMBUSTIBLE MIXTURE

FOR EXTERNAL USE ONLY
Not for Use in Humans.
Keep Out of Reach of Children.


Active Ingredient:



Copper Naphthenate ..................... 37.5% w/w


Inactive Ingredients:



........... 62.5% w/w
Total .....................................................100.0%


General Precautions



CAUTION: Do not use in horses intended for human consumption.

CAUTION: COMBUSTIBLE MIXTURE

Use in a well-ventilated place.  Avoid fire, flame, sparks or heaters.

If swallowed, do not induce vomiting, call physician immediately.  Avoid breathing vapor.  Avoid contact with skin and eyes.

Keep out of reach of children and pets.


General Directions:



Clean the hoof thoroughly, removing debris and necrotic material prior to application of KOPERTOX®. Apply daily to affected hoofs with a narrow paint brush (about 1") until fully healed. Caution: Do not allow runoff of excess KOPERTOX® onto hair since contact with KOPERTOX® may cause some hair loss.  Do not contaminate feed.


Storage And Handling



Store at controlled room temperature 15° to 30°C (59° to 86°F).  Keep container tightly closed when not in use.


Information For Owners/Caregivers



NOTE: KOPERTOX® is easily removed from hands, clothing and surfaces with light grade fuel oil or any type of lighter fluid.

CONTAINS FOIL SEAL – REMOVE BEFORE USE.

SHAKE WELL BEFORE USE.


Contact Information:



To report suspected adverse drug events, for technical assistance or to obtain a copy of the Safety Data Sheet (SDS) contact Zoetis Inc. at
1-888-963-8471. For additional information about adverse drug experience reporting for animal drugs, contact FDA at 1-888-FDA-VETS or http://www.fda.gov/reportanimalae


How Supplied



236 mL (8 oz)   Rev. 03/2023  5164100

473 mL (16 oz)  Rev. 03/2023  5161100

Approved by FDA under ANADA # 200-304

Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007

Manufactured by:
First Priority, Inc.
Elgin, IL 60123


236 Ml (8 Oz)




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