Label: DURVET PENNOX 50 - oxytetracycline powder

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

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/12

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  • PRINCIPAL DISPLAY PANEL

    durvet 
     
    NDC: 30798-375-56

    Pennox 50
    OXYTETRACYCLINE

    Type A Medicated Article

    FOR USE IN THE MANUFACTURE OF MEDICATED FEEDS  
    DO NOT FEED UNDILUTED
    ACTIVE DRUG INGREDIENT:
    Oxytetracycline (from oxytetracycline dihydrate base) equivalent to 50 grams Oxytetracycline Hydrochloride/lb.
    INGREDIENTS:
    Oxytetracycline, Calcium Carbonate, Roughage Products and Mineral Oil.
    See back panel for directions and warnings.

    FOR USE IN DRY ANIMAL FEED ONLY.  NOT FOR USE IN LIQUID FEED SUPPLEMENTS.  
    NADA 138-938    APPROVED BY FDA 
     
    Restricted Drug (California) -
    Use Only as Directed
    NOT FOR HUMAN USE

    NET WT.
    50 lb (22.7kg)

    durvet
    Manufactured for
    DURVET, INC.
    Blue Springs, Missouri 64014
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  • PRINCIPAL DISPLAY PANEL

    durvet

    NDC: 30798-375-56

    Pennox 50

    OXYTETRACYCLINE

    DIRECTIONS FOR USE

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  • INDICATIONS & USAGE


    Use Levels of Oxytetracycline lbs. of Pennox 50 per ton
    Indications for Use

    CHICKENS

    For Broiler/fryer Chickens: For an increased weight gain and
    10-50 g/ton
    0.2-1.0
    improved feed efficiency. (Use continuously)

    WARNING:Do not feed to chickens producing eggs for human


    consumption. Zero-day withdrawal period. In low calcium feeds, withdraw


    3 days prior to slaughter


    For Chickens:  Control of infectious synovitis caused by Mycoplasma 100-200 g/ton
    2.0-4.0
    synoviae; control of fowl cholera caused by Pasteurella multocida

    sensitive to oxytetracycline. (Feed continuously for 7-14 days)


    WARNING: Do not feed to chickens producing eggs for human


    consumption. Zero-day withdrawal period. In low calcium feeds, withdraw


    3 days prior to slaughter.


    For Chickens: Control of chronic respiratory disease (CRD) and air sac
    400 g/ton
    8.0
    infection caused by Mycoplasma gallisepticum and Escherichia coli

    susceptible to oxytetracycline. (Feed continuously for 7-14 days)


    WARNING: Do not feed to chickens producing eggs for human


    consumption. Zero-day withdrawal period. In low calcium feeds, withdraw


    3 days before slaughter.


    For Broiler Chickens: Reduction of mortality due to air sacculitis (air-sac-
    500 g/ton
    10.0
    infection) caused by Escherichia coli susceptible to oxytetracycline.


    (Feed continuously for 5 days)


    WARNING: Do not feed to chickens producing eggs for human


    consumption. 24 hour withdrawal period. In low calcium feeds, withdraw


    3 days before slaughter.



    TURKEYS
    For Growing Turkeys:
    For an increased rate of weight gain
    10-50 g/ton
    0.2-1.0
    and improved feed efficiency. (Use continuously)


    WARNING:  Do not feed to turkeys producing eggs for human


    consumption.


    For Turkeys: Control of hexamitiasis caused by Hexamila meleagridis 100 g/ton
    2.0
    susceptible to oxytetracycline. (Feed continuously for 7-14 days)


    WARNING: Do not feed to turkeys producing eggs for human


    consumption.
    For Turkeys: Control of infectious synovitis caused by Mycoplasma
    200 g/ton
    4.0
    synoviae susceptible to oxytetracycline. (Feed continuously for 7-14 days)


    WARNING: Do not feed to turkeys producing eggs for human


    consumption.


    For Turkeys: Control of complicating bacterial organisms associated
    25 mg/lb. body weight/day

    with bluecomb (transmissible enteritis, coronaviral enteritis)


    susceptible to oxytetracycline. (Feed continuously for 7-14 days)


    WARNING: Do not feed to turkeys producing eggs for human consumption.


    Zero-day withdrawal period.





    SHEEP


    For Sheep: For an increased rate of weight gain and improved fee
    10-20 g/ton
    0.20-0.4
    efficiency. (Use continuously)


    For Sheep: Treatment of bacterial enteritis caused by Escherichia coli 10 mg/lb. body weight/day

    and bacterial pneumonia caused by Pasteurella multocida susceptible


    to oxytetracycline. (Feed continuously for 7-14 days)


    WARNING: 5 day withdrawal period at 10 mg/lb. dosage.






    Use Levels of Oxytetracycline
    lbs. of Pennox 50 per ton
    Indications for Use

    SWINE

    For Swine: For an increased rate of weight gain and improved
    10-50 g/ton
    0.20-1.0
    feed efficiency. (Use continuously)


    For Swine: Treatment of bacterial enteritis caused by Escherichia coli Feed approximately 400 g/ton,

    and Salmonella choleraesuis susceptible to oxytetracycline and
    varying with body weight and

    treatment of bacterial pneumonia caused by Pasteurella multocida feed consumption to provide

    susceptible to oxytetracycline. (Feed continuously for 7-14 days)
    10 mg/lb. body weight/day

    For Breeding Swine: Control and treatment of leptospirosis
    Feed approximately 400 g/ton,

    (reducing the incidence of abortion and shedding leptospirae)
    varying with body weight and

    caused by Leptospira pomona susceptible to oxytetracycline.
    feed consumption to provide

    (Feed continuously for 14 days)
    10 mg/lb. body weight/day

    WARNING: Zero-day withdrawal period.





    CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE

    For Calves (up to 250 lbs.): For an increased rate of weight
    0.05-0.1 mg/lb. body weight/day

    gain and improved feed efficiency. (Use continuously)


    For Calves (250-400 lbs.): For an increased rate of weight gain and
    25 mg/head/day

    improved feed efficiency. (Use continuously)


    For Growing Cattle (over 400 lbs.): for an increased rate of weight gain,
    75 mg/head/day

    improved feed efficiency and reduction of liver condemnation due to liver


    abcesses. (Use continuously)


    For Cattle: For the prevention and treatment of the early stages of the
    0.5-2.0 g/head/day

    shipping fever complex. (Feed 3-5 days before and after arrival in


    feedlots.)


    For Calves, Beef Cattle and Nonlactating Dairy Cattle: Treatment of
    10 mg/lb. body weight/day

    bacterial enteritis caused by Escherichia coli and bacterial pneumonia


    (shipping fever complex) caused by Pasteurella multocida susceptible


    to oxytetracycline. (Feed continuously for 7-14 days)


    WARNING: 5 day withdrawal period at 10 mg/lb. dosage.





    HONEY BEES

    For Honey Bees:  For control of American Foulbrood caused by
    200 mg/colony

    Paenibacillus larvae, and European Foulbrood caused by Streptococcus

    pluton susceptible to oxytetracycline.


    WARNING: Remove at least 6 weeks prior to main honey flow.
    (Use directions available upon request.)


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  • PRINCIPAL DISPLAY PANEL

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  • INGREDIENTS AND APPEARANCE
    DURVET PENNOX 50 
    oxytetracycline powder
    Product Information
    Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL Item Code (Source) NDC:30798-375
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    OXYTETRACYCLINE (OXYTETRACYCLINE ANHYDROUS) OXYTETRACYCLINE 110 g  in 1 kg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30798-375-56 22.7 kg in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA138938 12/23/2008
    Labeler - Durvet, Inc. (056387798)
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