ENGAIN 9- ractopamine hydrochloride powder

Engain 9 by

Drug Labeling and Warnings

Engain 9 by is a Animal medication manufactured, distributed, or labeled by Zoetis Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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)

INGREDIENTS AND APPEARANCE

ENGAIN 9 
ractopamine hydrochloride powder

Product 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)