Label: LINCOMIX 50- lincomycin hydrochloride granule

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

Drug Label Information

Updated December 8, 2022

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  • SPL UNCLASSIFIED SECTION

    Type A Medicated Article

    50 grams/lb

    Caution: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

     

    For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broilers.

    For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) casued by Lawsonia intracellularis.

    For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae.

    Each pound contains:

    Active Drug Ingredient

                       Lincomycin………………………………..50 grams

                       (as lincomycin hydrochloride agricultural grade)

                    Inactive Ingredients  

                       Soybean hulls, #20 grind; light liquid paraffin, Ph.Eur.

     

    IMPORTANT:

    Must be thoroughly mixed in feeds before use.

    Store opened bag in dry place to prevent caking.

     Store at room temperature.

     

    Approved by FDA under NADA # 097-505

  • BROILERS

    BROILERS

    For the control of necrotic enteritis caused or complicated by Clostridium spp. or other organisms susceptible to lincomycin in broilers.

    DIRECTIONS FOR USE

    For the control of necrotic enteritis:

    LINCOMIX 50, 50 grams/lb, should be mixed into the complete feed supplied to broiler chickens so that the final feed contains 2 grams of lincomycin per ton of feed.

    MIXING DIRECTIONS

    Type C Medicated Feeds

    Intermediate Premix

    Amount of LINCOMIX 50 per 1000 lb

    (454 kg) of Feed Ingredients
     

    Complete Feed

    Amount of Intermediate Premix to Provide 2 Grams

    of lincomycin per ton of Type C Medicated Feed

    lincomycin per ton of feed

    2 grams

     20 lbs

    4 lbs

    2 lbs

     2 lbs

    10 lbs

    20 lbs

      

    WARNING: When using LINCOMIX 50 in approved combinations with other drugs, follow the required withdrawal times for those drugs. No drug withdrawal period is required before slaughter of birds fed LINCOMIX 50 at the approved concentration (2 grams lincomycin per ton of feed).

    CAUTION: Not for use in layers, breeders, or turkeys. (For additional Cautions, see below.)


  • SWINE

    SWINE

    For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis. For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae.

    DIRECTIONS FOR USE

    For the treatment of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis:

    Feed 100 grams of lincomycin per ton of complete feed as the sole ration for three weeks, or until signs of disease (watery, mucoid or bloody stools) disappear.

    For the treatment and control of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis:

    Feed 100 grams of lincomycin per ton of complete feed as the sole ration for three weeks, or until signs of disease (watery, mucoid or bloody stools) disappear, followed by 40 grams of lincomycin per ton.

    For the control of swine dysentery and porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis: Feed 40 grams of lincomycin per ton of complete feed as the sole ration. For use in animals or on premises with a history of swine dysentery, but where symptoms have not yet occurred.

    For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae:

    Feed 100-200 grams of lincomycin per ton of complete feed as the sole ration for 21 days.

    MIXING DIRECTIONS

    Type C Medicated Feeds

    For treatment of swine dysentery, and the control of porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis:

    To make complete feed containing 100 grams of lincomycin, add 2 lbs of LINCOMIX 50 per ton.

    For control of swine dysentery and porcine proliferative enteropathies (ileitis) caused by Lawsonia intracellularis:

    To make complete feed containing 40 grams of lincomycin, add 0.8 lbs of LINCOMIX 50 per ton.

    For reduction in the severity of the effects of respiratory disease associated with Mycoplasma hyopneumoniae:

    To make complete feed containing 100- 200 grams of lincomycin, add 2-4 lbs of LINCOMIX 50 per ton.

    Additional mixing directions to make complete feed containing 40, 100 or 200 grams of lincomycin per ton are provided below.

    MIXING DIRECTIONS

     

    IntermediatePremix

    Amount of LINCOMIX 50 per 1000 lb

    (454 kg) of Feed Ingredients

    Complete Feed

    Amount of Intermediate Premix to Provide Desired Grams of lincomycin per ton of Type C Medicated Feed

    lincomycin per ton of feed

     

    50 lbs

    40 lbs

    20 lbs

     

    40 grams              100 grams            200 grams

       16 lbs                     40 lbs                      80 lbs

       20 lbs                     50 lbs                     100 lbs

       40 lbs                     100 lbs                   200 lbs


    WARNING: When using LINCOMIX 50 in approved combinations with other drugs, follow the required withdrawal times for those drugs. No drug withdrawal period is required before slaughter of swine fed LINCOMIX 50 at approved concentrations (40, 100 or 100-200 grams lincomycin per ton of feed).

    NOT FOR HUMAN USE

    CAUTION: Occasionally, swine fed lincomycin may within the first two days after the onset of treatment develop diarrhea and/or swelling of the anus. On rare occasions, some pigs may show reddening of the skin and irritable behavior. These conditions have been self-correcting within five to eight days without discontinuing the lincomycin treatment. The effects of lincomycin on swine reproductive performance, pregnancy, and lactation have not been determined.


  • SPL UNCLASSIFIED SECTION

    Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to feeds containing lincomycin. Ingestion by these species may result in severe gastrointestinal effects.

    Good Manufacturing Practices Should Be Observed in Preparing Feeds Containing LINCOMIX 50.

    This Includes Appropriate Clean-out Procedures to Avoid Cross-Contamination.

    Restricted Drug (California) – Use Only as Directed

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    501918

    40027871

    Made in China

  • PRINCIPAL DISPLAY PANEL

    Lincomix 50 bag label
  • INGREDIENTS AND APPEARANCE
    LINCOMIX 50 
    lincomycin hydrochloride granule
    Product Information
    Product TypeVFD TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:54771-1494
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LINCOMYCIN HYDROCHLORIDE (UNII: M6T05Z2B68) (LINCOMYCIN - UNII:BOD072YW0F) LINCOMYCIN50 g  in 0.453 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-1494-222.7 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA09750506/30/1976
    Labeler - Zoetis Inc. (828851555)