STAFAC 500- virginiamycin powder

Stafac 500 by

Drug Labeling and Warnings

Stafac 500 by is a Animal medication manufactured, distributed, or labeled by Phibro Animal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Type A Medicated Article Mix with swine and poultry feed

Active Drug Ingredient

Virginiamycin : 50%

(Contains 227g virginiamycin activity per lb)

Caution

CAUTION: Federal law restricts medicated feed containing this veterinary feed directive (VFD) drug to use by or on the order of a licensed veterinarian.

Inert Ingredients:

Calcium carbonate, carboxymethylcellulose, mineral oil

For Further Manufacture Only.

Follow Directions For Use.

NADA #91-467, Approved by FDA

301-8001-09

Stafac is a registered trademark of Phibro Animal Health Corporation

Distributed by: Phibro Animal Health Corporation, Teaneck, NJ 07666

Made in Canada

For use in swine and poultry feeds as specified below

Directions for Use

Mixing Directions—Swine

Stafac 500 Type A Medicated Article must be thoroughly mixed in the feed to assure even distribution. Determine the appropriate amount of Stafac 500 required from the table below. Dilute Stafac 500 with a portion of one of the feed ingredients (enough to make a quantity equal to 10 lb per ton) before final mixing.

Swine	Required level of virginiamycin activity per ton of Type C Medicated Feed (complete feed)	Required amount of Stafac 500 per ton of Type C Medicated Feed (complete feed)	Amount of virginiamycin activity provided to animal per lb of body weight per day
Treatment of swine dysentery in nonbreeding swine weighing over 120 lb	100 g for 2 weeks	200 g	2.27 mg
Treatment and control of swine dysentery in swine weighing up to 120 lb	100 g for 2 weeks followed by 50 g	200 g 100 g	2.27 mg 1.14 mg
Aid in control of swine dysentery in swine weighing up to 120 lb For use in animals or on premises with a history of swine dysentery but where symptoms have not yet occurred	25 g	50 g	0.57 mg
►Caution: Not for use in breeding swine over 120 pounds.◄
Mixing Directions—Poultry Mix 100 g Stafac 500 with enough of one of the feed ingredients to make 10 lb of an intermediate mix. Add 1 lb of the intermediate mix for each 5 g of virginiamycin needed to medicate a ton of feed.
Poultry		Required level of virginiamycin activity per ton of Type C Medicated Feed (complete feed)	Required amount of Stafac 500 per ton of Type C Medicated Feed (complete feed)
For use in broiler chickens
Prevention of necrotic enteritis caused by Clostridium perfringens susceptible to virginiamycin		20 g	40 g
Not for Use in Laying Chickens

Storage and Handling

Feed Continuously as Sole Ration

Store At Or Below 25oC (77oF), Excursions Permitted Up to 40oC (104oF)

Close Container After Use

NOT FOR HUMAN USE

Restricted Drug (California) – Use Only as Directed

Principal Display Panel

Stafac 500 Label.

INGREDIENTS AND APPEARANCE

STAFAC 500 
virginiamycin powder

Product Information
Product Type	VFD TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 66104-1501
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VIRGINIAMYCIN (UNII: C49WS9N75L) (VIRGINIAMYCIN - UNII:C49WS9N75L)	VIRGINIAMYCIN	227 g  in 0.45 kg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
MINERAL OIL (UNII: T5L8T28FGP)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
SOYBEAN OIL (UNII: 241ATL177A)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 66104-1501-9	45.3 kg in 1 DRUM
2	NDC: 66104-1501-1	25 kg in 1 BOX
3	NDC: 66104-1501-2	600 kg in 1 BAG
4	NDC: 66104-1501-3	800 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NADA	NADA091467	04/01/2010

Labeler - Phibro Animal Health (006989008)

Registrant - Phibro Animal Health (006989008)