Label: AUREOZOL GRANULAR 500 AUREOZOL 500G- chlortetracycline calcium, sulfathiazole and penicillin g procaine granule

  • NDC Code(s): 46573-022-00
  • Packager: Alpharma Inc. Animal Health
  • Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Animal Drug Application

Drug Label Information

Updated October 12, 2009

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Aureomycin® chlortetracycline,
    sulfathiazole and penicillin
    Type A Medicated Article

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  • Active drug ingredients

    Chlortetracycline calcium complex equivalent to

    Chlortetracycline HCl ............................................................................... 40 g / lb
    Sulfathiazole .................................................................................. 8.8% (40 g / lb)
    Penicillin (from procaine penicillin) .......................................................... 20 g / lb

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  • Ingredients

    Dried Streptomyces aureofaciens Fermentation Product and calcium sulfate.

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  • SPL UNCLASSIFIED SECTION

    For use in the manufacture of medicated swine feeds. For animal use only.

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  • Use directions

    Provide 100 g/ton chlortetracycline, 100 g/ton sulfathiazole, and 50 g/ton of penicillin by thoroughly mixing 2.5 lb (1.14 kg) of AureoZol 500 Granular into each ton (907.2 kg) of complete swine feed for the following indications.

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  • Type of swine feed – permitted claims and limitations

    For Use in Swine Feeds as Specified Below:

    Pre-starter and Starter Feeds

    Administer to swine in a complete medicated feed for reduction of the incidence of cervical abscesses; treatment of bacterial enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); maintenance of weight gains in the presence of atrophic rhinitis; increased rate of weight gain and improved feed efficiency from 10 pounds of body weight to 6 weeks postweaning. For swine raised in confinement (dry-lot) or on limited pasture.

    Grower and Finisher Feeds

    Administer to swine in a complete medicated feed for reduction of the incidence of cervical abscesses; treatment of bacterial enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); maintenance of weight gains in the presence of atrophic rhinitis; increased rate of weight gain from 6 to 16 weeks post-weaning. For swine raised in confinement (dry-lot) or on limited pasture.

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  • Caution

    In order to achieve the desired performance results, feed as the sole ration.

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  • Warning

    Withdraw 7 days prior to slaughter.

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  • SPL UNCLASSIFIED SECTION

    Note: Manufacture of Type B or C feeds from this product requires a Medicated Feed License Application approved by FDA.

    ANADA #200-167, Approved by FDA

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  • SPL UNCLASSIFIED SECTION

    Restricted Drug (California) - Use only as directed.
    Not for human use.

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  • SPL UNCLASSIFIED SECTION

    Marketed by
    Alpharma Inc.
    Bridgewater, New Jersey 08807

    Net wt 50 LB (22.68 kg)

    Take Time Observe Label Directions

    Made in USA

    Trademarks
    registered by
    Alpharma Inc.

    700339 0909

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  • PRINCIPAL DISPLAY PANEL - 50 LB Label

    AureoZol®
    Granular 500

    ALPHARMA

    Aureomycin® chlortetracycline,
    sulfathiazole and penicillin
    Type A Medicated Article

    See mixing directions, claims, cautions
    and warnings on back

    Net wt 50 LB (22.68 kg)

    ALPHARMA®

    AureoZol®
    Granular 500

    Principal Display Panel - 50 LB Label
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  • INGREDIENTS AND APPEARANCE
    AUREOZOL GRANULAR 500  AUREOZOL 500G
    chlortetracycline calcium, sulfathiazole and penicillin g procaine granule
    Product Information
    Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:46573-022
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Chlortetracycline Calcium (UNII: NR4B2SX17S) (Chlortetracycline - UNII:WCK1KIQ23Q) Chlortetracycline 40 g  in 0.45 kg
    Sulfathiazole (UNII: Y7FKS2XWQH) (Sulfathiazole - UNII:Y7FKS2XWQH) Sulfathiazole 40 g  in 0.45 kg
    Penicillin G (UNII: Q42T66VG0C) (Penicillin G - UNII:Q42T66VG0C) Penicillin G 20 g  in 0.45 kg
    Procaine (UNII: 4Z8Y51M438) (Procaine - UNII:4Z8Y51M438) Procaine 20 g  in 0.45 kg
    Inactive Ingredients
    Ingredient Name Strength
    Calcium Sulfate (UNII: WAT0DDB505)  
    Product Characteristics
    Color BROWN (light brown) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:46573-022-00 22.68 kg in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200167 01/01/2009
    Labeler - Alpharma Inc. Animal Health (070954094)
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