Animal NDC 58198-0630-9 Optaflexx 45

Ractopamine Hydrochloride

Animal Product Information

Field Name	Field Value
Animal NDC Code	58198-0630-9
Proprietary Name	Optaflexx 45 What is the Proprietary Name? The proprietary name also known as the trade name is the name of the product chosen by the medication labeler for marketing purposes.
Non-Proprietary Name	Ractopamine Hydrochloride What is the Non-Proprietary Name? The non-proprietary name is sometimes called the generic name. The generic name usually includes the active ingredient(s) of the product.
Labeler Name	Elanco Us Inc.
Product Type	Otc Type A Medicated Article Animal Drug
Usage Information	Thoroughly mix Optaflexx 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: a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound b Based on 90% Dry Matter Basis Pounds of Optaflexx 45 a To Add Per Ton To Make aType B Medicated Feed Resulting Ractopamine Concentration in Type B Medicated Feed bgrams/ton grams/pound 36.1 1,640 0.82 72.2 3,280 1.64 108.3 4,920 2.46 Thoroughly mix Optaflexx 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. a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound b Based on 90% Dry Matter Basis Pounds of Optaflexx 45 a Per Ton To Make a Type C Medicated Feed Resulting Ractopamine Concentration in Type C Medicated Feed b0.18 8.2 grams/ton (9 ppm) 0.36 16.4 grams/ton (18 ppm) 0.54 24.6 grams/ton (27 ppm)
Active Ingredient(s)	Ractopamine Hydrochloride
Marketing Category	NADA - NEW ANIMAL DRUG APPLICATION What is the Marketing Category? Product types are broken down into several potential Marketing Categories, such as NDA/ANDA/BLA, OTC Monograph, or Unapproved Drug. One and only one Marketing Category may be chosen for a product, not all marketing categories are available to all product types. Currently, only final marketed product categories are included. The complete list of codes and translations can be found at www.fda.gov/edrls under Structured Product Labeling Resources.
FDA Application Number	NADA141221 What is the FDA Application Number? This corresponds to the NDA, ANDA, or BLA number reported by the labeler for products which have the corresponding Marketing Category designated. If the designated Marketing Category is OTC Monograph Final or OTC Monograph Not Final, then the Application number will be the CFR citation corresponding to the appropriate Monograph (e.g. “part 341”). For unapproved drugs, this field will be null.

Optaflexx 45 Images

Optaflexx 45 (ractopamine hydrochloride Type A medicated article) label - image 01

Optaflexx 45 Animal Product Labeling Information

The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.

Other
Active Drug Ingredient:
Mixing Directions (Complete Feed):
Mixing Directions (Liquid Type B Feeds):
Mixing Directions For Preparing Type C Medicated Top Dress Feed:
Directions For Use (Complete Feed):
Directions For Use (Type C Medicated Top Dress Feed):
Warning
Storage And Handling
Principal Display Panel – 25 Lb Bag Label

Other

Elanco™

AF0630

Optaflexx™45

(ractopamine hydrochloride Type A medicated article)

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

Net Weight 25 lb
(11.34 kg)

Do Not Feed Undiluted

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.

Complete Feed

^a Based on 90% Dry Matter Basis
Indications	Appropriate Concentration of Ractopamine in Type C Medicated Feed ^a	Ractopamine (mg/hd/d)
Increased Rate of Weight Gain, and Improved Feed Efficiency	8.2 to 24.6 g/ton (9 ppm 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 ppm to 27 ppm)	90-430

^a 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.
NC = No Change, ↑ = Increased, ↓ = Decreased
^b Steers Only
^c Reduction indicates an improvement in USDA Yield Grade.
Carcass Measurements	Effect of Ractopamine^a
Carcass Measurements	8.2 grams/ton (9 ppm)	16.4 grams/ton (18 ppm)	24.6 grams/ton (27 ppm)
Hot Carcass Weight, lbs	↑	↑	↑
Dressing Percentage, %	NC	↑^b	↑^b
Carcass Percent Fat, %	NC	↓	↓
12th Rib Fat Thickness, in.	NC	NC	NC
Average Rib Eye Area, sq. in.	↑	↑	↑
USDA Yield Grade	NC	NC	↓^c
Marbling Score	NC	NC	NC
Rate of Carcass Lean Gain per Day	NC	↑	↑
Efficiency of Carcass Lean Gain per Day	NC	↑	↑

Top Dress Feed

^a Based on 90% Dry Matter Basis
Indications	Appropriate Concentration of Ractopamine in Type C Medicated Feed ^a	Ractopamine (mg/hd/d)
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^a (maximum of 800 g/ton)	70-400

Inert Ingredients: Ground corn cobs.

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.

Mixing Directions (Complete Feed):

Thoroughly mix Optaflexx 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:

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

Thoroughly mix Optaflexx 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.

^a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound
^b Based on 90% Dry Matter Basis
Pounds of Optaflexx 45 ^a Per Ton To Make a Type C Medicated Feed	Resulting Ractopamine Concentration in Type C Medicated Feed ^b
0.18	8.2 grams/ton (9 ppm)
0.36	16.4 grams/ton (18 ppm)
0.54	24.6 grams/ton (27 ppm)

Mixing Directions (Liquid Type B Feeds):

Thoroughly mix Optaflexx 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 at 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:

^a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound
Pounds of Optaflexx 45 ^a 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
36.1	1,640	0.82
44.1	2,000	1.00
50.7	2,300	1.15

Mixing Directions For Preparing Type C Medicated Top Dress Feed:

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

^a Optaflexx 45 contains 45.4 g ractopamine hydrochloride per pound
^b Based on 90% Dry Matter Basis
Pounds of Optaflexx 45 ^a To Add Per Ton To Make Type C Medicated Top Dress Feed	Resulting Ractopamine Concentration in Type C Top Dress Medicated Feed ^b
Top Dress	grams/ton	grams/pound	mg/pound
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

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/head/ 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/head/day.

CAUTION: Not for animals intended for breeding.

Warning

Withdrawal Period:

No withdrawal period is required when used according to labeling.

NOT FOR HUMAN USE

Storage And Handling

Store at Room Temperature. 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 -

Approved by FDA under NADA # 141-221

Optaflexx™ 45

Manufactured for: Elanco US, Inc

Greenfield, IN 46140, USA

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

Optaflexx, Elanco and the diagonal bar logo are trademarks of Elanco or its affiliates.

YL230548X

Principal Display Panel – 25 Lb Bag Label