SACOX 60- salinomycin powder

Sacox 60 by

Drug Labeling and Warnings

Sacox 60 by is a Animal medication manufactured, distributed, or labeled by Huvepharma, Inc., Huvepharma EOOD. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

FRONT PANEL

Brand of salinomycin sodium
Type A Medicated Article

For use in broiler, roaster, replacement
(breeder and layer) chickens, and quail only

Active Drug Ingredient

Salinomycin equivalent to 60 grams salinomycin sodium activity per pound

For use in manufacturing medicated feeds only

Other Ingredients

Calcium Carbonate, Mineral Oil, Calcium Silicate and Silicon Dioxide

Indications for Use

Broiler, roaster and replacement (breeder and layer) chickens

Use Sacox 60 to provide salinomycin sodium concentrations ranging from 40-60 g/ton (0.0044% to 0.0066%) for the prevention of coccidiosis in broiler, roaster and replacement chickens caused by Eimeria tenella, E. necatrix, E. acervulina, E. maxima, E. brunetti and E. mivati. The dosage should be adjusted to meet the severity of the coccidial challenge, which varies with environmental and management conditions.

Quail

Use Sacox 60 to provide salinomycin sodium concentrations of 50 g/ton (0.0055%) for the prevention of coccidiosis in quail caused by Eimeria dispersa and E. lettyae.

For use in manufacturing medicated feeds only

WHEN USING

Mixing Directions
Thoroughly mix Sacox® 60 with non-medicated feed to provide the
level of salinomycin sodium per ton as indicated in the table below.

• Saliomycin Sodium Activity: Amount of Sacox® 60 Type A Medicated; Article (60 g/lb) Per Ton of Feed

(grams per ton)	Lbs	Grams
40	0.67	304
45	0.75	341
50	0.83	377
55	0.92	418
60	1.00	454

Feeding DirectionsFeed continuously as the sole ration

Important
Must be thoroughly mixed in feeds before use. Not approved for use with pellet binders.

GENERAL PRECAUTIONS

Caution

No withdrawal required. May be fatal if accidentally fed to adult turkeys or to horses

WARNINGS

Warning

Do not feed to laying hens producing eggs for human consumption. When mixing and handling Sacox 60 premix, use protective clothing, impervious gloves, eye protection, and an approved dust respirator. Operators should wash thoroughly with soap and water after handling. If accidental eye contact occurs, immediately rinse thoroughly with water

STORAGE AND HANDLING

Storage and Handling

Store in a cool, dry place

ANADA #200-075, Approved by FDA

Distributed by:

Huvepharma, Inc.

Peachtree City, GA 30269

Net Wt. 50 lb. (22.68 kg)

Bag Label Image

INGREDIENTS AND APPEARANCE

SACOX 60 
salinomycin powder

Product Information
Product Type	OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG	Item Code (Source)	NDC: 23243-2050
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SALINOMYCIN (UNII: 62UXS86T64) (SALINOMYCIN - UNII:62UXS86T64)	SALINOMYCIN	60 g  in 0.45 kg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM CARBONATE (UNII: H0G9379FGK)
CALCIUM SILICATE (UNII: S4255P4G5M)
MINERAL OIL (UNII: T5L8T28FGP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	white ((Off White to Tan))	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 23243-2050-5	22.68 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200075	06/29/2009

Labeler - Huvepharma, Inc. (619153559)

Registrant - Huvepharma EOOD (552691651)

Establishment
Name	Address	ID/FEI	Business Operations
Huvepharma, Inc.		883128204	manufacture, analysis, medicated animal feed manufacture