Label: ENGAIN 9- ractopamine hydrochloride powder
- NDC Code(s): 54771-8727-1
- Packager: Zoetis Inc.
- Category: OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Animal Drug Application
Drug Label Information
Updated June 18, 2020
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- INFORMATION FOR OWNERS/CAREGIVERS
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DESCRIPTION
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 Feed4.5 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.
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,
a Improvement was observed only in pigs weighing less than 250 lbs.
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 ↑ ↑ ↑ -
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
- CAUTION
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BOXED WARNING
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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
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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 – Approved by FDA under ANADA # 200-542
Distributed by:
Zoetis Inc.
Kalamazoo, MI 49007Product of United Kingdom
Engain™ 9
To report adverse effects, access medical information, or obtain additional product information, call 1-888-963-8471.
51061600
- PRINCIPAL DISPLAY PANEL - 11.34 kg Bag Label
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INGREDIENTS AND APPEARANCE
ENGAIN 9
ractopamine hydrochloride powderProduct Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG Item Code (Source) NDC:54771-8727 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RACTOPAMINE HYDROCHLORIDE (UNII: 309G9J93TP) (RACTOPAMINE - UNII:57370OZ3P1) RACTOPAMINE HYDROCHLORIDE 20 g in 1 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:54771-8727-1 11.34 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANADA ANADA200542 07/16/2013 Labeler - Zoetis Inc. (828851555)
