Zinc Bacitracin & Amprol HI-EŽ

FDA Approved Animal Drug Products
Online Database System
Drug Product Abstract
Please note that the US Code of Federal Regulations (21 CFR version April 1, 2000) is the official source of regulatory information concerning approved animal drug products.


105-758 (OTC)
Tradename(s) Zinc Bacitracin & Amprol HI-EŽ
Sponsor Roche Vitamins, Inc.
Ingredient(s) Amprolium; Bacitracin Zinc; Ethopabate; Roxarsone
Species Chicken, broilers excluding layers
Route(s) Per Os
DoseForm(s) Premix
Withdrawal Time Chicken (broilers): 5 days before slaughter.

CFR Indications
 
 
 
 
 
558.58 Amprolium and ethopabate.

Specifications:
Type A medicated articles: 25 percent amprolium and 8 percent ethopabate

Conditions of use:

Chickens (broilers)

Amount:
Amprolium 113.5 (0.0125 percent) grams per ton of feed and ethopabate 36.3 (0.004 percent) grams per ton of feed, in combination with Bacitracin, 10 to 50 grams per ton of feed plus roxarsone 15.4 to 45.4 (0.0017 percent to 0.005 percent) grams per ton of feed.

Indications:
As an aid in prevention of coccidiosis where severe exposure to coccidiosis from Eimeria acervulina, E. maxima, and E. brunetti is likely to occur; improved feed efficiency.

Limitations:
Do not feed to laying chickens. Withdraw 5 days before slaughter. As sole source of amprolium and organic arsenic. Do not use as a treatment for outbreaks of coccidiosis. Feed as the sole ration from time chicks are placed on litter until past the time when coccidiosis is ordinarily a hazard. Do not use in Type B or Type C medicated feeds containing bentonite.
 
 
 
 
 
 
 

To see the complete 21 CFR Part 558 58
CFR Tolerance
For Amprolium:
 
 
 
 
Amprolium.

Tolerances are established as follows for residues of amprolium (1-(4-amino-2-n- propyl-5-pyrimidinylmethyl)-2-picolinium chloride hydrochloride):
a. In chickens and turkeys (edible tissues):
(1) 1 part per million in uncooked liver and kidney.
(2) 0.5 part per million in uncooked muscle tissue.
b. In chicken and turkey eggs:
(1) 8 parts per million in egg yolks.
(2) 4 parts per million in whole eggs.
c. In calves (edible tissues):
(1) 2.0 parts per million in uncooked fat.
(2) 0.5 part per million in uncooked muscle tissue, liver, and kidney.
d. In pheasants (edible tissues):
(1) 1 part per million in uncooked liver.
(2) 0.5 part per million in uncooked muscle.
 
 
 
 
 
 For Ethopabate:
 
 
 
 
Ethopabate.

Tolerance for residues of ethopabate converted to metaphenetidine are established in the edible tissues of chickens as follows:
a. 1.5 parts per million in uncooked liver and kidney
b. 0.5 part per million in uncooked muscle
 
 
 
 
 
 For Bacitracin Zinc:
 
 
 
 
Bacitracin

The ADI for total residues of bacitracin is 0.05 milligram per kilogram of body weight per day.

The tolerance for residues of bacitracin from zinc bacitracin or bacitracin methylene disalicylate in uncooked edible tissues of cattle, swine, chickens, turkeys, pheasants, and quail, and in milk and eggs is 0.5 part per million
 
 
 
 
 
 For Roxarsone:
 
 
 
 
Arsenic.

Tolerances for total residues of combined arsenic (calculated as AS) in food are established as follows:
a. In chickens and turkeys (edible tissues):
(1) 0.5 part per million in uncooked muscle tissue.
(2) 2 parts per million in uncooked edible by-products.
b. In chicken and turkey eggs: 0.5 part per million
c. In swine (edible tissues):
(1) 2 parts per million in uncooked liver and kidney.
(2) 0.5 part per million in uncooked muscle tissue and by-products other than liver and kidney.
 
 
 
 
 
Agricultural Research Service

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