Label: ENGAIN 9- ractopamine hydrochloride powder

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

Drug Label Information

Updated October 30, 2013

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

  • INFORMATION FOR OWNERS/CAREGIVERS

    For Use in Finishing Swine Feeds Only

    Net Weight 25 lbs (11.34 kg)

  • 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
    *
    No increased benefit has been shown when ractopamine concentrations in the diet are greater than 4.5 g/ton (5 ppm).
     4.5 to 9.0 g/ton*
    (5 to 10 ppm)

    Inert Ingredients: Ground corncobs.

    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
     NC= No Change, ↑ = increased, ↓ = decreased,
    *
    Improvement was observed only in pigs weighing less than 250 lbs.
     Carcass Fat ↓* ↓* ↓ ↓
     10th Rib Backfat (3/4 location) NC NC NC ↓
     Last Rib Backfat (midline) NC NC NC NC
     Loin Eye Area (10th Rib) ↑* ↑ ↑ ↑
     Rate of Lean Gain ↑ ↑ ↑ ↑
     Efficiency of Lean Gain ↑ ↑ ↑ ↑
     Dressing Percentage NC ↑ ↑ ↑
  • DOSAGE & ADMINISTRATION

    Mixing Directions: Thoroughly mix Engain 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 Engain 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 Engain 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 Engain 9 to Add per Ton To Make a 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)
  • SAFE HANDLING WARNING

    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

    WARNING: The active ingredient in Engain, 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 Engain formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Engain, 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 1-888-963-8471.

  • STORAGE AND HANDLING

    Store below 25°C (77°F), excursions permitted to 40°C (104°F). Avoid Moisture.

  • SPL UNCLASSIFIED SECTION

    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 – ANADA # 200-542, Approved by FDA
    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

    Engain™ 9

    To report adverse effects, access medical information, or obtain additional product information, call 1-888-963-8471.

    For Use in
    Swine Only

    Read Label
    Instructions
    Carefully

    Not for
    Human Use

    8RAC401 Rev: 07/13
    Product No.: 1RAC401
    3831000
    13742901

  • PRINCIPAL DISPLAY PANEL - 11.34 kg Bag Label

    For Use in Finishing Swine Feeds Only

    Engain™ 9
    Ractopamine Hydrochloride

    Net Weight 25 lbs (11.34 kg)

    PRINCIPAL DISPLAY PANEL - 11.34 kg Bag Label
  • INGREDIENTS AND APPEARANCE
    ENGAIN 9 
    ractopamine hydrochloride powder
    Product Information
    Product TypeOTC TYPE A MEDICATED ARTICLE ANIMAL DRUGItem Code (Source)NDC:54771-8727
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    RACTOPAMINE HYDROCHLORIDE (UNII: 309G9J93TP) (RACTOPAMINE - UNII:57370OZ3P1) RACTOPAMINE HYDROCHLORIDE20 g  in 1 kg
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:54771-8727-111.34 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANADAANADA20054207/16/2013
    Labeler - Zoetis Inc. (828851555)