Label: PAYLEAN 9- ractopamine hydrochloride granule

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

Drug Label Information

Updated November 1, 2018

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  • SPL UNCLASSIFIED SECTION

    Elanco™

    AF0602

    Paylean™9

    (ractopamine hydrochloride
    Type A medicated article)

    For Use in Finishing Swine Feeds Only

    Do not feed undiluted.

    Net Weight 25 lbs
    (11.34kg)

  • SPL UNCLASSIFIED SECTION

    Active Drug Ingredient: ractopamine hydrochloride - 9 g per lb (20 g per kg)

    Important: Must be thoroughly mixed into feeds before use. Follow label directions.

  • INDICATIONS & USAGE

    Indication: For increased rate of weight gain, improved feed efficiency and increased carcass leanness in finishing swine, weighing not less than 150 lbs, fed a complete ration containing at least 16% crude protein for the last 45 to 90 lbs of gain prior to slaughter.

    Appropriate Concentration of Ractopamine in Type C
    Medicated Feed
    4.5 to 9.0 g/ton*
    (5 to 10 ppm)
    * No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.5 g/ton (5 ppm).

    Inert Ingredients: Ground corncobs.

    NC = No Change, ↑ = increased, ↓ = decreased,

    a Improvement was observed only in pigs weighing less than 250 lbs.

    Last 45 lbs of body weight gainLast 90 lbs of body weight gain
    Variable4.5 g/ton ractopamine 9.0 g/ton ractopamine 4.5 g/ton ractopamine 9.0 g/ton ractopamine
    Carcass Fat aa
    10th Rib Backfat (3/4 location) NC NC NC
    Last Rib Backfat (midline) NC NC NC NC
    Loin Eye Area (10th Rib) a
    Rate of Lean Gain
    Efficiency of Lean Gain
    Dressing Percentage NC
  • DOSAGE & ADMINISTRATION

    Mixing Directions: Thoroughly mix Paylean 9 Type A Medicated Article into one ton of appropriate feed ingredients according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 4920 g/ton). The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

    Pounds of Paylean 9 To Add Per Ton
    To Make a Type B Medicated Feed
    Resulting Ractopamine Concentration in Type B Medicated Feed
    grams/ton grams/pound
    100 900 0.45
    200 1,800 0.90
    300 2,700 1.35
    400 3,600 1.80

    Thoroughly mix Paylean 9 Type A Medicated Article into one ton of complete swine feed according to the table below to obtain the proper concentration in the Type C Medicated Feed. Prepare an intermediate pre-blend of the premix prior to mixing in a complete feed. Thoroughly mix the required amount in a convenient quantity of feed ingredients, then add to the remaining feed ingredients to make a ton of complete feed.

    Pounds of Paylean 9 To Add
    Per Ton of Type C Medicated Feed
    Resulting Ractopamine Concentration
    in Type C Medicated Feed
    0.5 4.5 grams/ton (5 ppm)
    1.0 9 grams/ton (10 ppm)
  • DOSAGE & ADMINISTRATION

    Feeding Directions: Feed continuously as the sole ration to finishing swine weighing not less than 150 lbs for the last 45 to 90 lbs (group average) of weight gain prior to slaughter.

    CAUTION: Ractopamine may increase the number of injured and/or fatigued pigs during marketing.

    Not for use in breeding swine.

    NOT FOR HUMAN USE

  • BOXED WARNING (What is this?)

    WARNING: The active ingredient in Paylean, ractopamine hydrochloride, is a beta-adrenergic agonist. Individuals with cardiovascular disease should exercise special caution to avoid exposure. Not for use in humans. Keep out of the reach of children. The Paylean 9 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Paylean, use protective clothing, impervious gloves, protective eye wear, and a NIOSH-approved dust mask. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse eyes thoroughly with water.

    If irritation persists, seek medical attention. The material safety data sheet contains more detailed occupational safety information. To report adverse effects, access medical information, or obtain additional product information, call 1-800-428-4441.

  • STORAGE AND HANDLING

    Storage information: Store at less than or equal to 25°C (77°F).

    Excursions to 40°C (104°F) are acceptable. Avoid excessive moisture.

    Expiration Date and Lot Number are printed on the bag. Not to be used after the expiry date.

    Restricted Drug (California) - Use Only as Directed - NADA # 140-863, Approved by FDA

    Manufactured for: Elanco US, Inc

    Greenfield, IN 46140, USA

    Paylean9

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

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

    TAKE TIME
    OBSERVE LABEL
    DIRECTIONS

    BG101327X

  • Principal Display Panel – 25 lbs Bag Label

    Elanco™

    AF0602

    Paylean™9

    (ractopamine hydrochloride
    Type A medicated article)

    For Use in Finishing Swine Feeds Only

    Do not feed undiluted.

    Net Weight 25 lbs
    (11.34kg)

    Principal Display Panel – 25 lbs Bag Label
  • INGREDIENTS AND APPEARANCE
    PAYLEAN 9 
    ractopamine hydrochloride granule
    Product Information
    Product TypeVFD TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:58198-0602
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ractopamine hydrochloride (UNII: 309G9J93TP) (ractopamine - UNII:57370OZ3P1) ractopamine hydrochloride20 g  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    soybean oil (UNII: 241ATL177A)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58198-0602-911.34 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NADANADA14086305/24/2010
    Labeler - Elanco US Inc. (966985624)