Label: CLINACOX- diclazuril granule
- NDC Code(s): 58198-0659-1, 58198-0659-2
- Packager: Elanco US Inc.
- Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Animal Drug Application
Drug Label Information
Updated April 24, 2023
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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.
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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.
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, USAProduct of China
Clinacox, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.
© 2022 Elanco or its affiliates
YL102389X
YL103383X - Principal Display Panel - 25 lbs Bag Label
- Principal Display Panel - 20 kg Bag Label
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INGREDIENTS AND APPEARANCE
CLINACOX
diclazuril granuleProduct Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:58198-0659 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Diclazuril (UNII: K110K1B1VE) (Diclazuril - UNII:K110K1B1VE) Diclazuril 0.9 g in 1 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:58198-0659-1 11.33 kg in 1 BAG 2 NDC:58198-0659-2 20 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NADA NADA140951 12/04/2001 Labeler - Elanco US Inc. (966985624)
