KOPERTOX- copper naphthenate liquid

KOPERTOX by

Drug Labeling and Warnings

KOPERTOX by is a Animal medication manufactured, distributed, or labeled by Zoetis, FIRST PRIORITY INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

WATER-RESISTANT PROTECTION WITHOUT BANDAGING

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

PRECAUTIONS

Do not use in horses intented for human consumption.

CAUTION:  COMBUSTIBLE MIXTURE

Ingredients:

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

INACTIVE INGREDIENT

Inert Ingredients............................................ 62.5% w/w

Total............................................................... 100%

INFORMATION FOR OWNERS/CAREGIVERS

FOR EXTERNAL USE ONLY

For Animal Use Only.

Keep Out of Reach of Children.

INDICATIONS & USAGE

Indicated in the treatment of thrush in horses and ponies

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.

ADVERSE REACTIONS

To report suspected adverse reactions or to obtain technical assistance, call 1-800-1-888-963-8471.

HOW SUPPLIED

236 mL (8 oz)   Rev. 02-14  0754I 30175400

473 mL (16 oz)  Rev. 02-14 0755J 30175500

ANADA 200-304, Approved by FDA

Distributed by:

Zoetis Inc.

Kalamazoo, MI 49007

Manufactured by:

First Priority, Inc.

Elgin, IL 60123

PRINCIPAL DISPLAY PANEL

Image of 236 mL bottle/case label (rev. 02/14)

PRINCIPAL DISPLAY PANEL

Image of 473 mL bottle/case label (rev. 02-14)

INGREDIENTS AND APPEARANCE

KOPERTOX 
copper naphthenate liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 54771-1100
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
COPPER NAPHTHENATE (UNII: 9J2IBN2H70) (COPPER - UNII:789U1901C5)	COPPER NAPHTHENATE	0.825 g  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54771-1100-1	12 in 1 CASE
1		236 mL in 1 BOTTLE, DISPENSING
2	NDC: 54771-1100-2	12 in 1 CASE
2		473 mL in 1 BOTTLE, DISPENSING

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200304	09/18/2014

Labeler - Zoetis (828851555)

Establishment
Name	Address	ID/FEI	Business Operations
FIRST PRIORITY INCORPORATED		179925722	manufacture