Animal NDC 58198-1542-1 Skycis

Narasin

Animal Product Information

Field Name	Field Value
Animal NDC Code	58198-1542-1
Proprietary Name	Skycis 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	Narasin 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
Active Ingredient(s)	Narasin
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	NADA141340 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.

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Skycis 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
Indication:
Warnings:
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Elanco™

AF1542

Skycis™ 100

(narasin Type A medicated article)

With Microtracer^®

For Use in Swine Feeds only

Do Not Feed Undiluted

Important: Must be thoroughly mixed into feeds before use. Follow label directions.

Mixing Directions: Thoroughly mix Skycis 100 Type A Medicated Article with non-medicated swine feed according to the table below to obtain the proper concentration in the Type B Medicated Feed (maximum 5,400 g/ton). The following table gives examples of how some Type B Medicated Feed concentrations can be prepared:

Pounds of Skycis 100 To Add per Ton To Make a Type B Medicated Feed	Resulting Narasin Concentration in Type B Medicated Feed [grams/ton (grams/pound)]
55.12	2,500 (1.25)
110.23	5,000 (2.50)

Thoroughly mix Skycis 100 Type A Medicated Article with a 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 complete feed.

Pounds of Skycis 100 to Add Per Ton of Type C Medicated Feed	Resulting Narasin Concentration in Type C Medicated Feed
0.3 lb	13.6 g/ton (15 ppm)
0.4 lb	18.1 g/ton (20 ppm)
0.6 lb	27.2 g/ton (30 ppm)

Caution: Do not allow adult turkeys, horses or other equines access to narasin formulations. Ingestion of narasin by these species has been fatal. Not approved for use in breeding animals because safety and effectiveness have not been evaluated in these animals.

Swine being fed with Skycis (narasin) should not have access to feeds containing pleuromutilins (e.g., tiamulin) as adverse reactions may occur. If signs of toxicity occur, discontinue use.

NOT FOR HUMAN USE.

Indication:

Indications	Appropriate Concentration of Narasin in Type C Medicated Feed
For increased rate of weight gain in growing-finishing swine when fed for at least 4 weeks	13.6 to 27.2 g/ton (15 ppm to 30 ppm)
For increased rate of weight gain and improved feed efficiency in growing-finishing swine when fed for at least 4 weeks	18.1 to 27.2 g/ton (20 ppm to 30 ppm)

No increased benefit in rate of weight gain has been shown when narasin concentrations in the diet are greater than 15 ppm (13.6 g/ton).

Active Ingredients: Narasin – 100 g per kg

Inactive Ingredients: Roughage products.

Feeding Directions: Feed continuously for at least four weeks to swine during the growing-finishing period as the sole ration. Effectiveness has not been demonstrated when fed for durations less than four weeks.

Warnings:

Withdrawal Period

No withdrawal period is required when used according to the label

When mixing and handling Skycis, use protective clothing, impervious
gloves and a dust mask. Operators should wash thoroughly with soap
and water after handling. If accidental eye contact occurs, immediately
rinse thoroughly with water.

Store at or below 25°C (77°F). Excursions permitted to 37°C (99°F).

Not to be used after the date printed on the bag.

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

Skycis 100

Manufactured For: Elanco US Inc.
Greenfield, IN 46140, USA

Restricted Drug (California) – Use Only as Directed

Approved by FDA under NADA # 141-340

Net Weight: 25 kg
(55.12 lb)

TAKE TIME

OBSERVE LABEL
DIRECTIONS

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

Microtracer^® is a trademark of Micro-Tracers, Inc., USA used under license.

BG103780X

Principal Display Panel - 25 Kg Bag Label