TYLAN 100 (TYLOSIN PHOSPHATE) GRANULE [ELANCO US INC.]

TYLAN 100 (TYLOSIN PHOSPHATE) GRANULE [ELANCO US INC.]
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NDC 58198-0099-1
Set ID 0cb546ce-5db1-47a7-85b0-b6800ecb3315
Category VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
Packager Elanco US Inc.
Generic Name
Product Class
Product Number
Application Number NADA012491
  • SPL UNCLASSIFIED SECTION

    AF0099
    BG102345X
    Elanco
    Tylan™ 100

    Net Weight: 50 lbs
    (22.68 kg)

    Tylosin Phosphate

    Type A Medicated Article

    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 use in Swine and Beef Cattle Feeds Only

    Do Not Feed Undiluted

    Equivalent to 100 g Tylosin per Pound

  • Swine:

    For reduction in severity of effects of atrophic rhinitis.

    For control of swine dysentery associated with Brachyspira hyodysenteriae.

    For the treatment and control of swine dysentery associated with Brachyspira hyodysenteriae immediately after medicating with Tylan Soluble (tylosin) drinking water.

    For control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis.

    For control of porcine proliferative enteropathies (PPE, ileitis) associated with Lawsonia intracellularis immediately after medicating with Tylan Soluble (tylosin) in drinking water.

  • Beef Cattle:

    For reduction of incidence of liver abscesses associated with Fusobacterium necrophorum and Arcanobacterium pyogenes.

    Restricted Drug (California) - Use Only as Directed.

    Approved by FDA under NADA # 012-491

    Tylan, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

    Manufactured For:

    Elanco US Inc.

    Greenfield, IN 46140, USA

    To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

    AF0099
    BG102345X

    Elanco

    Tylan100 Tylosin Phosphate

    Directions for Use

    Read All Directions Carefully Before Mixing and Feeding

    Tylan 100 Type A Medicated Article

    Net Weight 50 lbs (22.68 kg)

    Do Not Feed Undiluted.

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

  • SPL UNCLASSIFIED SECTION

    Active Drug Ingredient—Tylosin (as tylosin phosphate) . . . 100 g per lb

  • INACTIVE INGREDIENT

    Ingredients: Roughage products, calcium carbonate and mineral oil.

    Caution: To ensure adequate mixing, an intermediate blending step should be used prior to manufacturing a complete feed. Do not use in any liquid feed containing sodium metabisulfite or in any finished feed (supplement, concentrate or complete feed) containing in excess of 2% bentonite.

  • WARNINGS

    Warning: Tylan 100 may be irritating to unprotected skin and eyes. When mixing and handling Tylan 100 use protective clothing, impervious gloves and a dust respirator. In case of accidental eye exposure, flush eyes with plenty of water. Exposed skin should be washed with plenty of soap and water. Remove and wash contaminated clothing. Seek medical attention if irritation becomes severe or persists. The material safety data sheet (MSDS) contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

    For reduction in severity of effects of atrophic rhinitis. Feed 100 g of tylosin per ton (1.0 pound Tylan 100 per ton) of complete feed. Feed continuously as the sole ration.

    For control of swine dysentery. Feed 100 g of tylosin per ton (1.0 pound Tylan 100 per ton) of complete feed for at least three weeks. Follow with 40 g tylosin per ton (0.4 pound Tylan 100 per ton) of complete feed until pigs reach market weight.

    For the treatment and control of swine dysentery. Feed 40 to 100 grams of tylosin (0.4 to 1.0 pounds of Tylan 100) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin (as Tylan Soluble) per gallon in drinking water for 3 to 10 days.

    For control of porcine proliferative enteropathies (PPE, ileitis). Feed 100 g of tylosin per ton (1.0 pound Tylan 100 per ton) of complete feed for 21 days. Alternatively, feed 100 g of tylosin per ton (1.0 pound Tylan 100 per ton) of complete feed for at least three weeks, followed by 40 g tylosin per ton of complete feed until pigs reach market weight. Alternatively, feed 40 to 100 grams of tylosin (0.4 to 1.0 pounds of Tylan 100) per ton of complete feed for 2 to 6 weeks immediately after medicating with 250 mg tylosin (as Tylan Soluble) per gallon in drinking water for 3 to 10 days. Feed continuously as the sole ration when feeding Tylan.

    NOTICE: Organisms vary in their degree of susceptibility to any chemotherapeutic. If no improvement is observed after recommended treatment, diagnosis and susceptibility should be reconfirmed.

    Mixing and Feeding
    Directions for
    Beef Cattle Feeds
    For reduction of incidence of liver abscesses in beef cattle associated with Fusobacterium necrophorum and Arcanobacterium pyogenes.
    Tylan 100 Per Ton Of Type C Feed Tylosin Per Ton Of Type C Feed
    0.08 to 0.10 lbs 8 to 10 g
    To be fed so that each animal receives not more than 90 mg per head per day and not less than 60 mg per head per day.
    Feed continuously as the sole ration.
    Mixing Directions for
    Liquid Type B
    Cattle Feeds
    LIMITATIONS:
    1. pH must be between 4.5 and 6.0.
    2. For liquid feeds stored in recirculating tank systems: Recirculate immediately prior to use for not less than 10 minutes, moving not less than 1 percent of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not used.
    3. For liquid feeds stored in mechanical, air, or other agitation-type tank systems: Agitate immediately prior to use for not less than 10 minutes, creating a turbulence at the bottom of the tank that is visible at the top. Agitate daily as described even when not used.
    4. Liquid Type B Cattle Feeds must bear an expiration date of 31 days after the date of manufacture.

    NOT FOR HUMAN USE

  • STORAGE AND HANDLING

    Store at Room Temperature, 25°C (77°F). Avoid moisture.
    Not to be used after the date printed on the bottom of the bag.

    Logo

  • Principal Display Panel - 50 lbs Bag Label

    Elanco
    Tylan100

    Net Weight: 50 lbs
    (22.68 kg)

    Tylosin Phosphate

    Type A Medicated Article

    Principal Display Panel - 50 lbs Bag Label
  • INGREDIENTS AND APPEARANCE
    TYLAN 100 
    tylosin phosphate granule
    Product Information
    Product TypeVFD TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:58198-0099
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    tylosin phosphate (UNII: NR75X12AFF) (tylosin - UNII:YEF4JXN031) tylosin phosphate100 g  in .45 kg
    Inactive Ingredients
    Ingredient NameStrength
    mineral oil (UNII: T5L8T28FGP)  
    rice bran (UNII: R60QEP13IC)  
    calcium carbonate (UNII: H0G9379FGK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-0099-122.68 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA01249101/08/2010
    Labeler - Elanco US Inc. (966985624)
    Establishment
    NameAddressID/FEIBusiness Operations
    Elanco Clinton Laboratories039138631API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    Provimi North America, Inc.027859585MANUFACTURE, LABEL, PACK

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