Label: ACTOGAIN- 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 March 27, 2014

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  • BOXED WARNING(What is this?)

    WARNING: The active ingredient in Actogain, 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 Actogain 45 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Actogain, 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.

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  • SPL UNCLASSIFIED SECTION

    For Use in Feeds For Cattle Fed in
    Confinement for Slaughter Only

    Type A Medicated Article

    Do not Feed Undiluted

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  • DESCRIPTION

     Active Drug Ingredient: Ractopamine hydrochloride – 45.4 g per lb (100 g per kg)
     Important: Must be thoroughly mixed into feeds before use. Follow label directions.
     Indication: Complete Feed:     For increased rate of weight gain, improved feed efficiency and increased carcass leanness in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
     Top Dress Feed:     For increased rate of weight gain and improved feed efficiency in cattle fed in confinement for slaughter during the last 28 to 42 days on feed.
     Note:    Carcass leanness effects are not an approved indication for use when feeding ractopamine by Top Dress Feeding methods.
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  • Complete Feed

    Indications Appropriate Concentration of Ractopamine in Type C Medicated Feed* Ractopamine (mg/hd/d)
    *
    Based on 90% Dry Matter Basis
     Increased Rate of Weight Gain, and Improved Feed Efficiency  8.2 to 24.6 g/ton (9 to 27 ppm)  70-430
     Increased Rate of Weight Gain, Improved Feed Efficiency, and Increased Carcass Leanness  9.8 to 24.6 g/ton (11 to 27 ppm)  90-430
    Carcass Measurements Effect of Ractopamine*
    8.2 grams/ton (9 ppm) 16.4 grams/ton (18 ppm) 24.6 grams/ton (27 ppm)
     NC= No Change, ↑= increased, ↓ = decreased
    *
    The effect of ractopamine on parameters listed in this table is supported by data generated at the doses tested in the clinical field efficacy trials.
    Steers Only
    Reduction indicates an improvement in USDA Yield Grade.
     Hot Carcass Weight, lbs  ↑  ↑  ↑
     Dressing Percentage, %  NC  ↑  ↑
     Carcass Percent Fat, %  NC  ↓  ↓
     12th Rib Fat Thickness, in.  NC  NC  NC
     Average Rib Eye Area, sq. in.  ↑  ↑  ↑
     USDA Yield Grade  NC  NC  ↓
     Marbling Score  NC  NC  NC
     Rate of Carcass Lean Gain per Day  NC  ↑  ↑
     Efficiency of Carcass Lean Gain per Day  NC  ↑  ↑
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  • Top Dress Feed

    Indications Appropriate Concentration of Ractopamine in Type C Medicated Feed* Ractopamine (mg/hd/d)
    *
    Based on 90% Dry Matter Basis
     Increased Rate of Weight Gain and Improved Feed Efficiency  Appropriate Concentration of Ractopamine in a minimum of 1.0 lb Top Dressed Type C Medicated Feed* (maximum of 800 g/ton)  70-400

    Inert Ingredients: Ground corncobs.

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  • SPL UNCLASSIFIED SECTION

    Mixing Directions (Complete Feed): Thoroughly mix Actogain 45 Type A Medicated Article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 4,920 g/ton). The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

    Pounds of Actogain 45* to Add per Ton To Make a Type B Medicated Feed Resulting Ractopamine Concentration in Type B Medicated Feed
    grams/ton grams/pound
    *
    Actogain 45 contains 45.4g ractopamine hydrochloride per pound
    Based on 90% Dry Matter Basis
     36.1  1,640  0.82
     72.2  3,280  1.64
     108.3  4,920  2.46

    Thoroughly mix Actogain 45 Type A Medicated Article in a ton of complete cattle 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 one ton of complete feed.

    Pounds of Actogain 45* to Add per Ton To Make a Type C Medicated Feed Resulting Ractopamine Concentration in Type C Medicated Feed
    *
    Actogain 45 contains 45.4g ractopamine hydrochloride per pound
    Based on 90% Dry Matter Basis
     0.18  8.2 grams/ton (9 ppm)
     0.36  16.4 grams/ton (18 ppm)
     0.54  24.6 grams/ton (27 ppm)
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  • SPL UNCLASSIFIED SECTION

    Mixing Directions (Liquid Type B Feeds): Thoroughly mix Actogain 45 Type A Medicated Article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 2300 g/ton).

    Maintain supplement pH to 4.5 to 7.5. For stored liquid Type B medicated feeds containing ractopamine, recirculate immediately prior to use for not less than 10 minutes, moving not less than 1% of the tank contents per minute from the bottom of the tank to the top. Recirculate daily as described even when not in use.

    The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

    Pounds of Actogain 45* to Add per Ton To Make a Liquid Type B Medicated Feed Resulting Ractopamine Concentration in Liquid Type B Medicated Feed
    grams/ton grams/pound
    *
    Actogain 45 contains 45.4g ractopamine hydrochloride per pound
     36.1  1,640  0.82
     44.1  2,000  1.00
     50.7  2,300  1.15
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  • SPL UNCLASSIFIED SECTION

    Mixing Directions for preparing Type C Medicated Top Dress Feed: Thoroughly mix Actogain 45 Type A Medicated Article in a ton of appropriate feed ingredients or diluents according to the table below to obtain the proper concentration in the Type C Medicated Feed (maximum 800 g/ton). The following table gives examples of how some Type C Medicated Top Dress Feed concentrations can be prepared:

    Pounds of Actogain 45* to Add per Ton To Make a Type C Medicated Top Dress Feed Resulting Ractopamine Concentration in Type C Medicated Top Dress Feed
    Top Dress grams/ton grams/pound mg/pound
    *
    Actogain 45 contains 45.4g ractopamine hydrochloride per pound
    Based on 90% Dry Matter Basis
     2.20  100  0.05  50
     4.41  200  0.10  100
     6.61  300  0.15  150
     8.81  400  0.20  200
     17.62  800  0.40  400
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  • DOSAGE & ADMINISTRATION

    Directions for Use (Complete Feed): Feed continuously to cattle fed in confinement for slaughter as the sole ration for the last 28 to 42 days on feed.

    Directions for Use (Type C Medicated Top Dress Feed): Feed continuously to cattle fed in confinement for slaughter a Type C Medicated Feed containing up to a maximum of 800 g/ton ractopamine (see mixing direction table) to provide 70 to 400 mg per head per day for the last 28 to 42 days on feed. Type C Medicated Top Dress feed must be fed in a minimum of 1.0 lb per head per day to provide 70 to 400 mg per head per day.

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  • PRECAUTIONS

    CAUTION: Not for animals intended for breeding.

    NOT FOR HUMAN USE

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  • STORAGE AND HANDLING

    Store below 25ºC (77ºF), excursions permitted to 40ºC (104ºF). 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 – ANADA # 200-548, Approved by FDA

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  • SPL UNCLASSIFIED SECTION

    Distributed by:
    Zoetis Inc.
    Kalamazoo, MI 49007

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  • ADVERSE REACTIONS

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

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  • SPL UNCLASSIFIED SECTION

    Product No.: 1RAC402     3830000
    8RAC402 Rev: 07/13        13742501

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  • PRINCIPAL DISPLAY PANEL - 11.34 kg Bag

    For Use in Feeds For Cattle Fed in
    Confinement for Slaughter Only

    Actogain™ 45
    Ractopamine Hydrochloride

    Net Weight 25 lb (11.34 kg)

    PRINCIPAL DISPLAY PANEL - 11.34 kg Bag
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  • INGREDIENTS AND APPEARANCE
    ACTOGAIN 
    ractopamine hydrochloride powder
    Product Information
    Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:54771-8728
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    RACTOPAMINE HYDROCHLORIDE (UNII: 309G9J93TP) (RACTOPAMINE - UNII:57370OZ3P1) RACTOPAMINE HYDROCHLORIDE 100 g  in 1 kg
    Inactive Ingredients
    Ingredient Name Strength
    WATER (UNII: 059QF0KO0R)  
    SOYBEAN OIL (UNII: 241ATL177A)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:54771-8728-1 11.34 kg in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANADA ANADA200548 07/18/2013
    Labeler - Zoetis Inc. (828851555)
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