Animal NDC 58198-0659-1 Clinacox
Diclazuril

Animal Product Information

Field Name	Field Value
Animal NDC Code	58198-0659-1
Proprietary Name	Clinacox 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	Diclazuril 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	Elanco Us Inc.
Product Type	Otc Type A Medicated Article Animal Drug
Usage Information	Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati) and E. maxima.Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima.Growing Turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis and E. meleagrimitis.IMPORTANT: MUST BE THOROUGHLY MIXED INTO POULTRY FEEDS BEFORE USE.
Active Ingredient(s)	Diclazuril
Marketing Category	NADA - 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	NADA140951 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.

Clinacox Images

Clinacox 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.

Indications:
Directions:
Other
Principal Display Panel - 25 Lbs Bag Label
Principal Display Panel - 20 Kg Bag Label

Indications:

Broiler chickens: For the prevention of coccidiosis caused by Eimeria tenella, E. necatrix, E. acervulina, E. brunetti, E. mitis (mivati) and E. maxima.

Because diclazuril is effective against E. maxima later in its life cycle, subclinical intestinal lesions may be present for a short time after infection. Diclazuril was shown in studies to reduce lesion scores and improve performance and health of birds challenged with E. maxima.

Growing Turkeys: For the prevention of coccidiosis caused by Eimeria adenoeides, E. gallopavonis and E. meleagrimitis.

IMPORTANT: MUST BE THOROUGHLY MIXED INTO POULTRY FEEDS BEFORE USE.

Directions:

To manufacture a Type C medicated feed directly from the Type A medicated article: Thoroughly mix one pound (1 lb) of CLINACOX (0.2% diclazuril) into each ton of complete feed to provide 0.91 g/ton (1 ppm) of diclazuril (use level). It is recommended that an intermediate mix containing one part CLINACOX and not less than nine parts appropriate feed ingredient be thoroughly mixed before incorporation into the final feed.

To manufacture a Type B medicated feed and then a Type C medicated feed: Thoroughly mix 200 lbs of CLINACOX (0.2% diclazuril) with 1800 lbs unmedicated feed to produce 2000 lbs of Type B medicated feed containing 182 g/ton (200 ppm) diclazuril. Thoroughly mix 10 lbs of the resulting Type B medicated feed with 1990 lbs of unmedicated feed to produce 2000 lbs of Type C medicated feed containing 0.91 g/ton (1 ppm) diclazuril. The resulting Type C medicated feed should be fed continuously as the sole ration.

CAUTION: Do not feed to breeding turkeys.

WITHDRAWAL PERIODS AND RESIDUE WARNINGS

No withdrawal period is required when used according to labeling. Do not feed to birds producing eggs for human consumption.

Other

Adverse Event Reporting: To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

Net contents: 25 lbs (11.33 kg)
Net contents: 20 kg (44.09 lbs)

Store at or below 25°C (77°F), excursions permitted to 40°C (104°F).

Not to be used after the date printed on bag.

Restricted Drug (California) - Use Only as Directed

Not for human use.

Approved by FDA under NADA # 140-951

Manufactured for:
Elanco US Inc.
Greenfield, IN 46140, USA

Product of China

Clinacox, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

YL102389X
YL103383X

Principal Display Panel - 25 Lbs Bag Label

AF0659

Elanco™

Clinacox 0.2%

(diclazuril Type A
medicated article)

ACTIVE DRUG INGREDIENT: Diclazuril, 0.2%

INERT INGREDIENTS: Wheat middlings, calcium carbonate, soybean oil with 0.02% TBHQ (preservative), and silicon dioxide.

Principal Display Panel - 20 Kg Bag Label