Label: DURVET PENNCHLOR 50 - chlortetracycline calcium 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: 30798-373-56

    Pennchlor 50

    CHLORTETRACYCLINE  

    Type A Medicated Article

    FOR USE IN THE MANUFACTURE OF MEDICATED FEEDS  

    ACTIVE INGREDIENTS:

    Chlortetracycline as Chlortetracycline calcium complex equivalent to 50 grams Chlortetracycline

    Hydrochloride/lb.

    INGREDIENTS:

    Chlortetracycline, Calcium Carbonate, Roughage Products and Mineral Oil.

    See back panel for directions and warnings.

    CAUTION: For use in Dry Feeds ONLY - NOT FOR USE IN LIQUID FEED SUPPLEMENTS.

    NADA 138-935    APPROVED BY FDA

    Restricted Drug (California)-

    Use Only as Directed

    NOT FOR HUMAN USE

    NET WT.

    50 lb (22.7 kg)

    durvet

    Manufactured for

    DURVET, INC.

    Blue Springs, Missouri 64014

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  • PRINCIPAL DISPLAY PANEL

    durvet

    NDC: 30798-373-56

    Pennchlor 50

    CHLORTETRACYCLINE

    DIRECTIONS FOR USE

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  • INDICATIONS & USAGE



    lbs. of

    Use Levels of Pennchlor 50

    Chlortetracycline per ton
    Indications for Use




    CHICKENS


    For Broiler/fryer chickens: For an increased rate of weight gain and
    10-50 g/ton
    0.2-1.0
    improved feed efficiency.


    WARNING: Do not feed to chickens producing eggs for human


    consumption.  Zero-day withdrawal period.





    For Chickens: Control of infectious synovitis caused by Mycoplasma 100-200 g/ton
    2.0-4.0
    synoviae susceptible to chlortetracycline. (Feed continuously for 7-14


    days)


    WARNING: Do not feed to chickens producing eggs for human


    consumption.  Zero-day withdrawal period.





    For Chickens: Control of chronic respiratory disease (CRD) and air sac
    200-400 g/ton
    4.0-8.0
    infections caused by Mycoplasma gallisepticum and Escherichia coli

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


    WARNING: Do not feed to chickens producing eggs for human


    consumption.  Zero-day withdrawal period.





    For Chickens: Reduction of mortality due to Escherichia coli infections
    500 g/ton
    10.0
    susceptible to chlortetracycline. (Feed for 5 days)


    WARNING: Do not feed to chickens producing eggs for human


    consumption.  Withdraw 24 hours prior to slaughter.





    TURKEYS


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


    WARNING: Do not feed to turkeys producing eggs for human


    consumption.  Zero-day withdrawal period.





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


    WARNING: Do not feed to turkeys producing eggs for human


    consumption. Zero-day withdrawal period.





    For Turkeys: Control of hexamitiasis caused by Hexamita meleagrides 400 g/ton
    8.0
    susceptible to chlortetracycline. (Feed continuously 7-14 days)


    WARNING: Do not feed to turkeys producing eggs for human


    consumption. Zero-day withdrawal period.





    For Turkeys: Turkey poults not over 4 weeks of age: Reduction of
    400 g/ton
    8.0
    mortality due to paratyphoid caused by Salmonella typhimurium

    susceptible to chlortetracycline.





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

    with bluecomb (transmissible enteritis, coronaviral enteritis) susceptible


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


    WARNING: Do not feed to turkeys producing eggs for human


    consumption. Zero-day withdrawal period.





    SHEEP

    For Growing Sheep: For an increased rate of weight gain and improved
    20-50 g/ton
    0.4-1.0
    feed efficiency.





    For Breeding Sheep: Reducing the incidence of (vibrionic) abortion
    80 mg/head/day

    caused by Campylobacter fetus infections susceptible to chlortetracycline.


    WARNING: Zero-day withdrawal period.




    lbs. of

    Use Levels of Pennchlor 50

    Chlortetracycline
    per ton
    Indications for Use




    SWINE

    For Growing Swine:  For an increased rate of weight gain 10-50 g/ton
    0.2-1.0
    improved feed efficiency.





    For Swine: Reducing the incidence of cervical lymphadenitis
    50-100 g/ton
    1.0-2.0
    (jowl abscesses) caused by Group E Streptococci susceptible to


    chlortetracycline.





    For Breeding Swine: Control of leptospirosis (reducing the instances
    400 g/ton
    8.0
    of abortions and shedding of leptospirae) caused by Leptospira pomona

    susceptible to chlortetracycline. (Feed continuously for 14 days)





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

    and Salmonella choleraesius and bacterial pneumonia caused by
    varying with body weight and

    Pasteurella multocida susceptible to chlortetracycline. (Feed for not
    feed consumption to provide

    more than 14 days)
    10 mg/lb body weight/day

    WARNING: Zero-day withdrawal period.





    CALVES, BEEF CATTLE, AND NONLACTATING DAIRY CATTLE

    WARNING: A WITHDRAWAL PERIOD HAS NOT BEEN ESTABLISHED


    FOR THIS PRODUCT IN PRE-RUMINATING CALVES. DO NOT USE


    IN CALVES TO BE PROCESSED FOR VEAL.





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

    improved feed efficiency.





    For Calves (250-400 lbs.): For an increased rate of weight gain and
    25-70 mg/head/day

    improved feed efficiency.





    For Growing Cattle (over 400 lbs.): For an increased rate of weight
    70 mg/head/day

    gain, improved feed efficiency and reduction of liver condemnation


    due to liver abscesses.





    For Beef Cattle: For the control of bacterial pneumonia associated with
    350 mg/head/day

    shipping fever complex caused by Pasteurella spp. susceptible to


    chlortetracycline.


    WARNING: Zero-day withdrawal period.





    For Beef Cattle (under 700 lbs.): Control of active infection of anaplasmosis
    350 mg/head/day

    caused by Anaplasma marginale susceptible to chlortetracycline.


    WARNING: Zero-day withdrawal period.





    For Beef Cattle (over 700 lbs.): Control of active infection of
    0.5 mg/lb body weight/day

    anaplasmosis caused by Anaplasma marginale susceptible to


    chlortetraycline.


    WARNING: Zero-day withdrawal period





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

    bacterial enteritis caused by Escherichia coli and bacterial pneumonia


    caused by Pasteurella multocida susceptible to chlortetracycline.


    (Treat for not more than 5 days)


    WARNING: Zero-day withdrawal period.


    Enter section text here

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  • PRINCIPAL DISPLAY PANEL

    CAUTION: For use in Dry Feeds ONLY.

    NOT FOR USE IN LIQUID FEED SUPPLEMENTS  

    TAKE TIME    OBSERVE LABEL DIRECTIONS

    REV 12/05

    BAG T

    durvet

    Manufactured for

    DURVET, INC.

    Blue Springs, Missouri 64014

    Close
  • INGREDIENTS AND APPEARANCE
    DURVET PENNCHLOR 50 
    chlortetracycline powder
    Product Information
    Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL Item Code (Source) NDC:30798-373
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Chlortetracycline Calcium (Chlortetracycline) Chlortetracycline Calcium 110 g  in 1 kg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:30798-373-56 22.7 kg in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA138935 12/08/2007
    Labeler - Durvet, Inc. (056387798)
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