Label: ROBENZ- robenidine hydrochloride powder

  • Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Animal Drug Application

Drug Label Information

Updated April 8, 2020

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  • SPL UNCLASSIFIED SECTION

    Robenidine Hydrochloride
    Type A Medicated Article
    Coccidiostat

  • Active drug ingredient

    Robenidine hydrochloride 30 grams per pound (6.6%) in a carrier suitable for incorporation in feed.

  • PURPOSE

    For use in manufacturing medicated feeds only

  • Indications

    Broiler chickens

    As an aid in the prevention of coccidiosis caused by Eimeria mivati, E. brunetti, E. tenella, E. acervulina, E. maxima and E. necatrix in broiler chickens only.

  • Use directions

    Mix 1 pound of Robenz® Type A Medicated Article in one ton of feed to provide 30 grams per ton (0.0033%) robenidine hydrochloride concentration in feed. Feed continuously as the sole ration.

  • Caution

    Type C feeds containing Robenz robenidine hydrochloride must be fed within 50 days from the date of manufacture. Do not use this product in Type B or C medicated feeds containing bentonite

  • Warning

    Do not feed to chickens producing eggs for food. Withdraw 5 days prior to slaughter.

  • Note

    Manufacture of Type B and C feeds from this product requires a medicated feed mill license.

    Labels for feeds containing Robenz must contain appropriate indications, limitations and warnings as well as required feed ingredient information.

  • SPL UNCLASSIFIED SECTION

    Restricted Drug (California) - Use Only as Directed.

    Not for human use.

    Store below 25°C (77°F), excursions permitted to 37°C (99°F).

    Approved by FDA under NADA # 048-486

  • SPL UNCLASSIFIED SECTION

    zoetis

    Manufactured by:
    Zoetis LLC
    Salisbury, MD 21801

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    Product of Spain

    40027288

    Take Time

  • PRINCIPAL DISPLAY PANEL - 50 LB Bag

    50 LB Bag Label
  • INGREDIENTS AND APPEARANCE
    ROBENZ 
    robenidine hydrochloride powder
    Product Information
    Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:54771-1128
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ROBENIDINE HYDROCHLORIDE (UNII: 8STT15Y392) (ROBENIDINE - UNII:4888ME6C4E) ROBENIDINE HYDROCHLORIDE30 g  in 0.45 kg
    Product Characteristics
    ColorBROWN (Buff to Tan) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-1128-022.68 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA04848601/01/2009
    Labeler - Zoetis Inc. (828851555)
    Establishment
    NameAddressID/FEIBusiness Operations
    Zoetis LLC069370112MANUFACTURE
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