AureoZol

Dosage Form: FOR ANIMAL USE ONLY
AureoZol®

Granular 500

Aureomycin® chlortetracycline,

sulfathiazole and penicillin

Type A Medicated Article

Active drug ingredients

Chlortetracycline calcium complex equivalent to

Chlortetracycline HCl ............................................................................... 40 g / lb

Sulfathiazole .................................................................................. 8.8% (40 g / lb)

Penicillin (from procaine penicillin) .......................................................... 20 g / lb

Ingredients

Dried Streptomyces aureofaciens Fermentation Product and calcium sulfate.

For use in the manufacture of medicated swine feeds. For animal use only.

Use directions

Provide 100 g/ton chlortetracycline, 100 g/ton sulfathiazole, and 50 g/ton of penicillin by thoroughly mixing 2.5 lb (1.14 kg) of AureoZol 500 Granular into each ton (907.2 kg) of complete swine feed for the following indications.

Type of swine feed – permitted claims and limitations

For Use in Swine Feeds as Specified Below:

Pre-starter and Starter Feeds

Administer to swine in a complete medicated feed for reduction of the incidence of cervical abscesses; treatment of bacterial enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); maintenance of weight gains in the presence of atrophic rhinitis; increased rate of weight gain and improved feed efficiency from 10 pounds of body weight to 6 weeks postweaning. For swine raised in confinement (dry-lot) or on limited pasture.

Grower and Finisher Feeds

Administer to swine in a complete medicated feed for reduction of the incidence of cervical abscesses; treatment of bacterial enteritis (salmonellosis or necrotic enteritis caused by Salmonella choleraesuis and vibrionic dysentery); maintenance of weight gains in the presence of atrophic rhinitis; increased rate of weight gain from 6 to 16 weeks post-weaning. For swine raised in confinement (dry-lot) or on limited pasture.

Caution

In order to achieve the desired performance results, feed as the sole ration.

Warning

Withdraw 7 days prior to slaughter.

Note: Manufacture of Type B or C feeds from this product requires a Medicated Feed License Application approved by FDA.

ANADA #200-167, Approved by FDA

Restricted Drug (California) - Use only as directed.

Not for human use.

Marketed by

Alpharma Inc.

Bridgewater, New Jersey 08807

Net wt 50 LB (22.68 kg)

Made in USA

Trademarks

registered by

Alpharma Inc.

700339 0909

PRINCIPAL DISPLAY PANEL - 50 LB Label

AureoZol®

Granular 500

ALPHARMA

Aureomycin® chlortetracycline,

sulfathiazole and penicillin

Type A Medicated Article

See mixing directions, claims, cautions

and warnings on back

Net wt 50 LB (22.68 kg)

ALPHARMA®

AureoZol®

Granular 500

AureoZol GRANULAR 500  AureoZol 500G chlortetracycline calcium, sulfathiazole and penicillin g procaine  granule

Product Information Product Type OTC TYPE A MEDICATED ARTICLE ANIMAL DRUG NDC Product Code (Source) 46573-022 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlortetracycline Calcium (Chlortetracycline) Chlortetracycline 40 g  in 0.45 kg Sulfathiazole (Sulfathiazole) Sulfathiazole 40 g  in 0.45 kg Penicillin G (Penicillin G) Penicillin G 20 g  in 0.45 kg Procaine (Procaine) Procaine 20 g  in 0.45 kg

Inactive Ingredients Ingredient Name Strength Calcium Sulfate

Product Characteristics Color BROWN (light brown) Score      Shape Size Flavor Imprint Code Contains

Packaging # NDC Package Description Multilevel Packaging 1 46573-022-00 22.68 kg In 1 BAG None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
ANADA	ANADA200167	01/01/2009

Labeler - Alpharma Inc. Animal Health (070954094)

Revised: 10/2009Alpharma Inc. Animal Health