Topmax

Dosage Form: FOR ANIMAL USE ONLY
Topmax™ 9

ELANCO* AF0621

For Use in the Manufacture of Medicated Turkey Feed.

Topmax™ 9

Ractopamine

Hydrochloride

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.

Indications: Toms: For increased rate of weight gain and improved feed efficiency in finishing tom turkeys when fed for the last 14 days prior to slaughter.

Hens: For increased rate of weight gain and improved feed efficiency in finishing hen turkeys when fed for the last 7 to 14 days prior to slaughter.

Indications	Appropriate Concentration of
	Ractopamine in Type C Medicated Feed
	4.6 to 11.8 g/ton (5 ppm to 13 ppm)
Toms: Increased Rate of Weight Gain	No increased benefit has been shown when
and Improved Feed Efficiency	ractopamine concentrations in the diet are
	greater than 4.6 g/ton (5 ppm).
Hens: Increased Rate of Weight Gain
and Improved Feed Efficiency	4.6 to 11.8 g/ton (5 ppm to 13 ppm)

Inert Ingredients: Ground corn cobs.

Mixing Directions: Thoroughly mix Topmax 9 Type A Medicated Article into one 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 Topmax 9 To Add Per Ton	Resulting Ractopamine Concentration in Type B Medicated Feed
To Make a 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 Topmax 9 Type A Medicated Article into one ton of complete turkey 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 Topmax 9 to Add Per Ton of Type C Medicated Feed	Resulting Ractopamine Concentration in Type C Medicated Feed
0.5 lb	4.6 g/ton (5 ppm)
0.9 lb	8.2 g/ton (9 ppm)
1.3 lb	11.8 g/ton (13 ppm)

Feeding Directions: Feed continuously as the sole ration, 4.6 to 11.8 g/ton to finishing tom turkeys for the last 14 days prior to slaughter. Feed continuously as the sole ration, 4.6 to 11.8 g/ton to finishing hen turkeys for the last 7 to 14 days prior to slaughter.

CAUTION: Feeding ractopamine to tom turkeys during periods of excessive heat can result in increased mortality.

Not for animals intended for breeding.

NOT FOR HUMAN USE.

WARNING: The active ingredient in Topmax, 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 Topmax 9 formulation (Type A Medicated Article) poses a low dust potential under usual conditions of handling and mixing. When mixing and handling Topmax, 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.

Store at room temperature. Avoid moisture.

Expiration Date and Lot Number are printed on the bag. Not to be used after the expiry date.

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

Manufactured For: Elanco Animal Health

A Division of Eli Lilly and Company

Indianapolis, IN 46285, U.S.A.

Restricted Drug (California) – Use Only as Directed

NADA 141-290, Approved by FDA

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

YM9140DEAMM (V01-09-2008)

TAKE TIME TO

OBSERVE LABEL DIRECTIONS

Topmax™ 9

Net Weight 25 lb

(11.34 kg)

Topmax  ractopamine hydrochloride  granule

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 0986-0621 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength RACTOPAMINE HYDROCHLORIDE (RACTOPAMINE) RACTOPAMINE HYDROCHLORIDE 9 g  in 0.45 kg

Inactive Ingredients Ingredient Name Strength SOYBEAN OIL   WATER

Product Characteristics Color      Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 0986-0621-25 11.34 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA141290	04/01/2009

Labeler - Elanco Animal Health Co (807447169)

Establishment
Name	Address	ID/FEI	Operations
Eli Lilly and Company Limited (Speke Operations)		230761368	MANUFACTURE, ANALYSIS

Revised: 11/2008Elanco Animal Health Co