Label: PAYLEAN 9- ractopamine hydrochloride granule 

  • Label RSS
  • NDC Code(s): 0986-0602-09
  • Packager: Elanco Animal Health Co
  • 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 01/12

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

  • 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.

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  • SPL UNCLASSIFIED SECTION

    For Use in Finishing
    Swine Feeds Only

    Net Weight 25 lbs
    (11.34 kg)

    ELANCO* AF0602-25B

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  • Type A Medicated Article

    Do not feed undiluted.

    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.

    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.

    Variable Last 45 lbs of body weight gain Last 90 lbs of body weight gain
    4.5 g/ton ractopamine 9.0 g/ton ractopamine 4.5 g/ton ractopamine 9.0 g/ton ractopamine
    Carcass Fat a a
    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

    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)

    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

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  • SPL UNCLASSIFIED SECTION

    Store at room temperature. Avoid 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 Animal Health
                                     A Division of Eli Lilly and Company
                                     Indianapolis, IN 46285, USA

    Paylean® 9

    Figure

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

    *Elanco®, Paylean® and the diagonal color bar are trademarks of Eli Lilly and Company.

    BG5004DEAMB (V04-06-2007)

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  • Principal Display Panel

    Principal Display Panel - 25 lb Bag Label

    ELANCO* AF0602-25B

    Paylean® 9

    Ractopamine

    Hydrochloride

    For Use in Finishing

    Swine Feeds Only

    Net Weight 25 lbs

    (11.34 kg)

    Principal Display Panel - 25 lb Bag Label
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  • INGREDIENTS AND APPEARANCE
    PAYLEAN 9 
    ractopamine hydrochloride granule
    Product Information
    Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL Item Code (Source) NDC:0986-0602
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RACTOPAMINE HYDROCHLORIDE (RACTOPAMINE) RACTOPAMINE HYDROCHLORIDE 20 g  in 1 kg
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    SOYBEAN OIL  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0986-0602-09 11.34 kg in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NADA NADA140863 05/24/2010
    Labeler - Elanco Animal Health Co (807447169)
    Establishment
    Name Address ID/FEI Business Operations
    Eli Lilly and Company Limited 230761368 MANUFACTURE
    Establishment
    Name Address ID/FEI Business Operations
    Evonik Degussa Corporation 130890994 API MANUFACTURE
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